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Période en double aveugle (Partie A) : évaluer l’efficacité d’une dose unique de 100 µg de MM120 par rapport à un placebo sur des mesures supplémentaires de l’anxiété, du fonctionnement et de la qualité de vie chez des adultes atteints de TAG au cours de la période en double aveugle de 12 semaines.","language":34,"languageDescription":"French (France)"},{"id":10549750,"uuid":"b6619e2f-8218-4cf2-8e38-ce7d8c3f866b","attributeTranslation":"1. Etap badania prowadzony metodą podwójnie ślepej próby (Część A): Ocena skuteczności pojedynczej dawki 100 μg MM120 w porównaniu z placebo w dodatkowych miarach lęku, funkcjonowania i jakości życia u dorosłych z GAD w 12-tygodniowym okresie leczenia prowadzonego metodą podwójnie ślepej próby","language":19,"languageDescription":"Polish"}]},{"id":449645,"number":2,"secondaryObjective":"Open-label Extension (Part B): To evaluate the maintenance of efficacy of 100 μg MM120 on anxiety symptoms in adults with GAD over a 40-week open-label follow-up period with retreatment.","secondaryObjectiveTranslations":[{"id":10549752,"uuid":"c8f19d40-6d9f-4b02-b9d3-5f71c425f1f6","attributeTranslation":"2. Badanie kontynuacyjne prowadzone metodą otwartej próby (Część B): Ocena utrzymania skuteczności MM120 w dawce 100 μg w odniesieniu do objawów lękowych u dorosłych z GAD w 40-tygodniowym okresie kontrolnym prowadzonym metodą otwartej próby z zastosowaniem ponownego leczenia","language":19,"languageDescription":"Polish"},{"id":10549753,"uuid":"c8f19d40-6d9f-4b02-b9d3-5f71c425f1f6","attributeTranslation":"2. Période d’extension en ouvert (Partie B) : évaluer le maintien de l’efficacité de 100 µg de MM120 sur les symptômes d’anxiété chez des adultes atteints de TAG au cours de la période de suivi en ouvert de 40 semaines avec retraitement.","language":34,"languageDescription":"French (France)"}]},{"id":449646,"number":3,"secondaryObjective":"Open-label Extension (Part B): To evaluate the efficacy of 100 μg MM120 on other measures of anxiety symptoms, functioning and quality of life in adults with GAD over a 40-week open-label follow-up period with retreatment.","secondaryObjectiveTranslations":[{"id":10549755,"uuid":"76179718-bf85-472e-bf55-a97e023edcd3","attributeTranslation":"3. Période d’extension en ouvert (Partie B) : évaluer l’efficacité de 100 µg de MM120 sur d’autres mesures des symptômes d’anxiété, du fonctionnement et de la qualité de vie chez des adultes atteints de TAG au cours de la période de suivi en ouvert de 40 semaines avec retraitement.","language":34,"languageDescription":"French (France)"},{"id":10549754,"uuid":"76179718-bf85-472e-bf55-a97e023edcd3","attributeTranslation":"3. Badanie kontynuacyjne prowadzone metodą otwartej próby (Część B): Ocena skuteczności MM120 w dawce 100 μg w innych miarach objawów lękowych, funkcjonowania i jakości życia u osób dorosłych z GAD w 40-tygodniowym okresie kontrolnym prowadzonym metodą otwartej próby z zastosowaniem ponownego leczenia","language":19,"languageDescription":"Polish"}]},{"id":449647,"number":4,"secondaryObjective":"Open-label Extension (Part B):To evaluate the effect of 100 μg MM120 on sexual functioning in adults with GAD over a 40-week open-label period.","secondaryObjectiveTranslations":[{"id":10549757,"uuid":"70566992-329f-46d6-9e54-9196569f7c84","attributeTranslation":"4. Badanie kontynuacyjne prowadzone metodą otwartej próby (Część B): Ocena wpływu 100 μg MM120 na życie seksualne dorosłych z GAD w 40-tygodniowym okresie prowadzonym metodą otwartej próby","language":19,"languageDescription":"Polish"},{"id":10549756,"uuid":"70566992-329f-46d6-9e54-9196569f7c84","attributeTranslation":"4. Période d’extension en ouvert (Partie B) : évaluer l’effet d’une dose de 100 µg de MM120 sur le fonctionnement sexuel chez des adultes atteints de TAG au cours de la période en ouvert de 40 semaines.","language":34,"languageDescription":"French (France)"}]},{"id":449648,"number":5,"secondaryObjective":"Double-blind Period (Part A) key secondary: To evaluate the efficacy of a single dose of 100 μg MM120 versus placebo on additional measures of anxiety in adults with GAD.","secondaryObjectiveTranslations":[{"id":10549759,"uuid":"deb000d9-4526-4f5b-bebd-778fb263d292","attributeTranslation":"5. Etap badania prowadzony metodą podwójnie ślepej próby (Część A) – kluczowy drugorzędowy: Ocena skuteczności pojedynczej dawki 100 μg MM120 w porównaniu z placebo w dodatkowych miarach lęku u dorosłych z GAD.","language":19,"languageDescription":"Polish"},{"id":10549758,"uuid":"deb000d9-4526-4f5b-bebd-778fb263d292","attributeTranslation":"5. Critère secondaire clé de la période en double aveugle (Partie A): évaluer l’efficacité d’une dose unique de 100 μg de MM120 par rapport à un placebo sur des mesures supplémentaires de l’anxiété chez des adultes atteints de TAG.","language":34,"languageDescription":"French (France)"}]},{"id":449649,"number":6,"secondaryObjective":"6. Part A and Part B: To evaluate the maintenance of efficacy of 100 µg MM120 on anxiety symptoms in adults with GAD over the 52-week study.","secondaryObjectiveTranslations":[{"id":10549761,"uuid":"19455b26-ba74-4c08-ac67-10478b9ea7bf","attributeTranslation":"6. Partie A et Partie B : évaluer le maintien de l’efficacité de 100 µg de MM120 sur les symptômes d’anxiété chez des adultes atteints de TAG au cours de l’étude de 52 semaines.","language":34,"languageDescription":"French (France)"},{"id":10549760,"uuid":"19455b26-ba74-4c08-ac67-10478b9ea7bf","attributeTranslation":"6. Części A i B: ocena utrzymania skuteczności 100 µg MM120 względem objawów lękowych u dorosłych z GAD w okresie 52 tygodni badania.","language":19,"languageDescription":"Polish"}]},{"id":449650,"number":7,"secondaryObjective":"7.\tPart A and Part B: To evaluate the durability of efficacy of single dose of 100 µg MM120 on anxiety symptoms in adults with GAD.","secondaryObjectiveTranslations":[{"id":10549762,"uuid":"f1297e75-d055-4d24-90a7-7497a4d1449a","attributeTranslation":"7. Części A i B: ocena trwałości skuteczności pojedynczej dawki 100 µg MM120 względem objawów lękowych u dorosłych z GAD.","language":19,"languageDescription":"Polish"},{"id":10549763,"uuid":"f1297e75-d055-4d24-90a7-7497a4d1449a","attributeTranslation":"7. Partie A et Partie B : évaluer la durabilité de l’efficacité d’une dose unique de 100 µg de MM120 sur les symptômes d’anxiété chez des adultes atteints de TAG.","language":34,"languageDescription":"French (France)"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":858307,"number":1,"principalInclusionCriteria":"1. Participant must be between 18 and 74 years of age inclusive, at the time of signing the informed consent.","principalInclusionCriteriaTranslations":[{"id":10549726,"uuid":"9e5a552a-af33-44d6-b92f-3d2f50a1b16a","attributeTranslation":"1. Uczestnik musi być w wieku od 18 do 74 lat włącznie w momencie podpisania świadomej zgody","language":19,"languageDescription":"Polish"},{"id":10549727,"uuid":"9e5a552a-af33-44d6-b92f-3d2f50a1b16a","attributeTranslation":"1. Le participant doit être âgé de 18 à 74 ans inclus, au moment de la signature du formulaire de consentement éclairé.","language":34,"languageDescription":"French (France)"}]},{"id":858308,"number":10,"principalInclusionCriteria":"10. Participant must have an adult support person/caregiver able to monitor them throughout the study, accompany them to and from visits where study drug is administered, and agree to be in personal contact with participant at least 3 days a week. This support person must be available throughout the clinical trial.","principalInclusionCriteriaTranslations":[{"id":10549729,"uuid":"7042b4a9-616a-4b10-81d9-0003128a20c6","attributeTranslation":"10. Le participant doit avoir une personne de confiance adulte / un aidant capable de le surveiller tout au long de l’étude, de l’accompagner lors des visites au cours desquelles le médicament à l’étude est administré, et qui accepte d’être en contact personnel avec le participant au moins 3 jours par semaine. Cette personne de confiance doit être disponible tout au long de l’essai clinique.","language":34,"languageDescription":"French (France)"},{"id":10549728,"uuid":"7042b4a9-616a-4b10-81d9-0003128a20c6","attributeTranslation":"10. Uczestnik musi mieć dorosłego pomocnika/opiekuna, który będzie mógł monitorować jego stan przez cały czas badania, będzie mu towarzyszyć w drodze na wizyty związane z podaniem badanego leku i z powrotem oraz zgodzi się na pozostawanie w osobistym kontakcie z uczestnikiem przez co najmniej 3 dni w tygodniu. Taka osoba udzielająca wsparcia musi być dostępna przez cały okres badania klinicznego.","language":19,"languageDescription":"Polish"}]},{"id":858309,"number":2,"principalInclusionCriteria":"2. Diagnosis of DSM-5 GAD based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI).","principalInclusionCriteriaTranslations":[{"id":10549730,"uuid":"add3ef64-2036-4066-b38c-0119f32d5ad8","attributeTranslation":"2. Diagnostic de TAG selon le DSM-5 d’après l’évaluation clinique et confirmé par le mini-entretien neuropsychiatrique international (Mini-International Neuropsychiatric Interview, MINI).","language":34,"languageDescription":"French (France)"},{"id":10549731,"uuid":"add3ef64-2036-4066-b38c-0119f32d5ad8","attributeTranslation":"2. Rozpoznanie DSM-5 GAD w oparciu o ocenę kliniczną i potwierdzone przez wersję MINI Międzynarodowego Wywiadu Neuropsychiatrycznego (MINI)","language":19,"languageDescription":"Polish"}]},{"id":858310,"number":3,"principalInclusionCriteria":"3. HAM-A Total Score ≥20 at Screening (Visit 1) and Baseline (Visit 2).","principalInclusionCriteriaTranslations":[{"id":10549732,"uuid":"c5d08a33-c9b4-4981-90aa-24921289cf5a","attributeTranslation":"3. Łączny wynik HAM-A ≥20 podczas wizyty przesiewowej (wizyta 1) i wizyty wyjściowej (wizyta 2).","language":19,"languageDescription":"Polish"},{"id":10549733,"uuid":"c5d08a33-c9b4-4981-90aa-24921289cf5a","attributeTranslation":"3. Score total HAM-A ≥ 20 à la visite de sélection (Visite 1) et à la visite de référence (Visite 2).","language":34,"languageDescription":"French (France)"}]},{"id":858311,"number":4,"principalInclusionCriteria":"4. MADRS Items 1, 7, and 8 are ≤3 at Screening (Visit 1) and Baseline (Visit 2). Note: participant must not currently meet criteria for a major depressive episode.","principalInclusionCriteriaTranslations":[{"id":10549734,"uuid":"ad34c549-d16f-4beb-a289-ce14aa127eb7","attributeTranslation":"4. Wynik ≤3 dla pozycji 1, 7 i 8 skali MADRS podczas wizyty przesiewowej (wizyta 1) i wizyty wyjściowej (wizyta 2). Uwaga: uczestnik nie może obecnie spełniać kryteriów epizodu dużej depresji.","language":19,"languageDescription":"Polish"},{"id":10549735,"uuid":"ad34c549-d16f-4beb-a289-ce14aa127eb7","attributeTranslation":"4. Les items 1, 7 et 8 du MADRS sont ≤ 3 à la visite de sélection (Visite 1) et à la visite de référence (Visite 2). Remarque : le participant ne doit pas actuellement répondre aux critères d’un épisode dépressif majeur.","language":34,"languageDescription":"French (France)"}]},{"id":858312,"number":5,"principalInclusionCriteria":"5. Participant meets independent assessment for eligibility.","principalInclusionCriteriaTranslations":[{"id":10549736,"uuid":"ef9d3c48-8be9-475c-8ba4-2d8ac420fe28","attributeTranslation":"5. Le participant remplit les critères d’évaluation indépendants pour l’éligibilité.","language":34,"languageDescription":"French (France)"},{"id":10549737,"uuid":"ef9d3c48-8be9-475c-8ba4-2d8ac420fe28","attributeTranslation":"5. Uczestnik spełnia kryteria kwalifikacyjne na podstawie niezależnej oceny.","language":19,"languageDescription":"Polish"}]},{"id":858313,"number":6,"principalInclusionCriteria":"6. Body mass index (BMI) within the range ≥18 to ≤38 kg/m2 (inclusive) at Screening (Visit 1).","principalInclusionCriteriaTranslations":[{"id":10549738,"uuid":"0c6d55bb-3952-4c80-9ada-754cc5be1475","attributeTranslation":"6. Wskaźnik masy ciała (BMI) w zakresie od ≥18 do ≤38 kg/m2 (włącznie) podczas wizyty przesiewowej (wizyta 1).","language":19,"languageDescription":"Polish"},{"id":10549739,"uuid":"0c6d55bb-3952-4c80-9ada-754cc5be1475","attributeTranslation":"6. Indice de masse corporelle (IMC) compris entre ≥ 18 et ≤ 38 kg/m² (inclus) lors de la sélection (visite 1)","language":34,"languageDescription":"French (France)"}]},{"id":858314,"number":7,"principalInclusionCriteria":"7. Male or female: Willingness to use medically acceptable forms of contraception, when applicable, for the duration of their participation.","principalInclusionCriteriaTranslations":[{"id":10549740,"uuid":"714c84d5-bdf0-46ce-9bb1-ffb4bf514377","attributeTranslation":"7. Mężczyźni lub kobiety: Gotowość do stosowania medycznie dopuszczalnych metod antykoncepcji, jeśli dotyczy, przez cały czas trwania udziału w badaniu.","language":19,"languageDescription":"Polish"},{"id":10549741,"uuid":"714c84d5-bdf0-46ce-9bb1-ffb4bf514377","attributeTranslation":"7. Homme ou femme : volonté d’utiliser des moyens de contraception médicalement acceptables, le cas échéant, pendant la durée de la participation.","language":34,"languageDescription":"French (France)"}]},{"id":858315,"number":8,"principalInclusionCriteria":"8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.","principalInclusionCriteriaTranslations":[{"id":10549743,"uuid":"1bdd7cb5-b9e2-481d-af4d-007c5b7946a8","attributeTranslation":"8. Zdolność do podpisania świadomej zgody, co obejmuje przestrzeganie wymogów i ograniczeń wymienionych w formularzu świadomej zgody (ICF) oraz w protokole.","language":19,"languageDescription":"Polish"},{"id":10549742,"uuid":"1bdd7cb5-b9e2-481d-af4d-007c5b7946a8","attributeTranslation":"8. Être capable de donner un consentement éclairé signé, ce qui inclut le respect des exigences et des restrictions énumérées dans le formulaire de consentement éclairé (FCE) et dans le protocole.","language":34,"languageDescription":"French (France)"}]},{"id":858316,"number":9,"principalInclusionCriteria":"9. Must be in acceptable overall medical condition to participate in the study.","principalInclusionCriteriaTranslations":[{"id":10549745,"uuid":"f5a1eefd-8c0f-4ad8-b75e-665ead9cce63","attributeTranslation":"9. Aby wziąć udział w badaniu, ogólny stan zdrowia pacjenta musi być akceptowalny.","language":19,"languageDescription":"Polish"},{"id":10549744,"uuid":"f5a1eefd-8c0f-4ad8-b75e-665ead9cce63","attributeTranslation":"9. Être dans un état de santé général acceptable pour participer à l’étude.","language":34,"languageDescription":"French (France)"}]}],"principalExclusionCriteria":[{"id":1468054,"number":1,"principalExclusionCriteria":"1. A psychiatric disorder, other than GAD, that was the primary focus of treatment as defined by the DSM-5 and assessed by the MINI within 6 months before Screening.","principalExclusionCriteriaTranslations":[{"id":10549664,"uuid":"5ae73c80-1c30-4c82-980d-529e4abb8a1f","attributeTranslation":"1. Zaburzenia psychiczne, inne niż GAD, będące głównym celem leczenia zdefiniowane na podstawie DSM-5 i ocenione przez MINI w ciągu 6 miesięcy przed badaniem przesiewowym.","language":19,"languageDescription":"Polish"},{"id":10549665,"uuid":"5ae73c80-1c30-4c82-980d-529e4abb8a1f","attributeTranslation":"1. Un trouble psychiatrique, autre que le TAG, qui était le principal objectif du traitement tel que défini par le DSM-5 et évalué par le MINI dans les 6 mois précédant la visite de sélection.","language":34,"languageDescription":"French (France)"}]},{"id":1468055,"number":10,"principalExclusionCriteria":"10. Significant loss of hearing or vision that, in the opinion of the Investigator, may confound the results of the study or interfere with the ability of the site staff to provide adequate oversight of the participant during the study.","principalExclusionCriteriaTranslations":[{"id":10549667,"uuid":"54a27165-e3b3-4b64-b60d-1a0f53d487e6","attributeTranslation":"10. Znaczna utrata słuchu lub wzroku, która zdaniem badacza może zakłócić wyniki lub zakłócać zdolność personelu ośrodka do zapewnienia odpowiedniego nadzoru nad uczestnikiem podczas badania.","language":19,"languageDescription":"Polish"},{"id":10549666,"uuid":"54a27165-e3b3-4b64-b60d-1a0f53d487e6","attributeTranslation":"10. Perte significative de l’audition ou de la vision qui, de l’avis de l’investigateur, peut fausser les résultats de l’étude ou interférer avec la capacité du personnel du centre à assurer une surveillance adéquate du participant pendant l’étude.","language":34,"languageDescription":"French (France)"}]},{"id":1468056,"number":11,"principalExclusionCriteria":"11. Major trauma or surgery in the 3 months prior to randomization, or has any surgery scheduled to occur during the study that would require an overnight hospital stay.","principalExclusionCriteriaTranslations":[{"id":10549668,"uuid":"65b0ed96-e30e-46f4-9b23-029e4db0139b","attributeTranslation":"11. Traumatisme ou intervention chirurgicale majeur(e) dans les 3 mois précédant la randomisation, ou intervention chirurgicale programmée pendant l’étude qui nécessiterait une hospitalisation d’une nuit.","language":34,"languageDescription":"French (France)"},{"id":10549669,"uuid":"65b0ed96-e30e-46f4-9b23-029e4db0139b","attributeTranslation":"11. Poważny uraz lub zabieg chirurgiczny w ciągu 3 miesięcy przed randomizacją lub zaplanowany zabieg chirurgiczny w trakcie badania, który wymagałby pozostania na noc w szpitalu.","language":19,"languageDescription":"Polish"}]},{"id":1468057,"number":12,"principalExclusionCriteria":"12. Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at Screening, or are receiving treatment for Hepatitis B or C. Note: positive test results for participants who have previously recovered from or have been vaccinated for hepatitis are not exclusionary if participant is asymptomatic.","principalExclusionCriteriaTranslations":[{"id":10549671,"uuid":"091acdc1-edd8-4be9-af05-b357cead150c","attributeTranslation":"12. Dodatni wynik badania na obecność antygenu powierzchniowego wirusa zapalenia wątroby typu B (HBsAg) lub przeciwciał przeciwko wirusowi zapalenia wątroby typu C (HCV) podczas badań przesiewowych lub stosowanie leków przeciwko wirusowemu zapaleniu wątroby typu B lub C. Uwaga: dodatnie wyniki badań dla uczestników, którzy wcześniej powrócili do zdrowia po zapaleniu wątroby lub zostali zaszczepieni przeciwko zapaleniu wątroby nie stanowią kryterium wykluczenia, jeśli uczestnik nie wykazuje objawów.","language":19,"languageDescription":"Polish"},{"id":10549670,"uuid":"091acdc1-edd8-4be9-af05-b357cead150c","attributeTranslation":"12. Être positif pour l’antigène de surface du virus de l’hépatite B (HBsAg) ou les anticorps anti-virus de l’hépatite C (VHC) à la visite de sélection, ou recevoir un traitement contre l’hépatite B ou C. Remarque : les résultats positifs aux tests de dépistage des participants s’étant précédemment rétablis ou ayant été vaccinés contre l’hépatite ne constituent pas un critère d’exclusion si le participant est asymptomatique.","language":34,"languageDescription":"French (France)"}]},{"id":1468058,"number":13,"principalExclusionCriteria":"13. Unstable human immunodeficiency virus (HIV) infection. Note: To be eligible, antiviral medication must be stable for 3 months prior to Screening and viral load undetectable at most recent check-up, within 6 months.","principalExclusionCriteriaTranslations":[{"id":10549672,"uuid":"0614abec-6a16-44f6-af15-f4cac858b4e3","attributeTranslation":"13. Infection par le virus de l’immunodéficience humaine (VIH) instable. Remarque: pour être éligible, le traitement médicamenteux antiviral doit être stable depuis 3 mois avant la visite de sélection et la charge virale indétectable lors du dernier bilan de santé, dans les 6 mois.","language":34,"languageDescription":"French (France)"},{"id":10549673,"uuid":"0614abec-6a16-44f6-af15-f4cac858b4e3","attributeTranslation":"13. Niestabilne zakażenie wirusem ludzkiego niedoboru odporności (HIV). Uwaga: aby pacjent mógł kwalifikować się do udziału w badaniu, dawka leków przeciwwirusowych musi być stabilna przez 3 miesiące przed badaniami przesiewowymi, a poziom wiremii niewykrywalny podczas ostatniej kontroli w ciągu 6 miesięcy.","language":19,"languageDescription":"Polish"}]},{"id":1468059,"number":14,"principalExclusionCriteria":"14. History of malignancy or treatment of malignancy within 2 years prior to Screening, excluding resected basal cell or squamous cell carcinoma of the skin or carcinoma in situ (CIS) of the cervix that has been resolved without further treatment.","principalExclusionCriteriaTranslations":[{"id":10549674,"uuid":"0f6a9543-c442-40f2-b9c7-ddcc66a1ca94","attributeTranslation":"14. Antécédents de tumeur maligne ou traitement d’une tumeur maligne dans les 2 ans précédant la visite de sélection, à l’exclusion d’un carcinome basocellulaire ou épidermoïde de la peau réséqué ou d’un carcinome in situ (CIS) du col de l’utérus qui s’est résolu sans autre traitement.","language":34,"languageDescription":"French (France)"},{"id":10549675,"uuid":"0f6a9543-c442-40f2-b9c7-ddcc66a1ca94","attributeTranslation":"14. Nowotwór złośliwy w wywiadzie lub leczenie nowotworu złośliwego w ciągu 2 lat przed badaniami przesiewowymi, z wyłączeniem podstawnokomórkowego raka skóry lub raka in situ (CIS) szyjki macicy, który został wyleczony operacyjnie bez dalszej terapii.","language":19,"languageDescription":"Polish"}]},{"id":1468060,"number":15,"principalExclusionCriteria":"15. Any of the following cardiovascular conditions: a. History of clinically significant arrhythmia (eg, long QT syndrome); valvular heart disease; pulmonary hypertension; treatment or hospitalization for a major cardiovascular event (eg, myocardial infarction, heart failure, stroke) within 1 year prior to Screening (Visit 1). b. Family history of significant arrhythmia or a first-degree relative with sudden, unexplained death under 40 years of age; history of unexplained syncopal episodes; uncontrolled hypokalemia or hypomagnesemia. c. Uncontrolled hypertension as determined by the Investigator, or blood pressure at the Screening visit above 140 mmHg systolic or 90 mmHg diastolic after approximately 5 minutes of rest.  \tNOTE: This population may experience anxiety in medical settings. If the first measurement of a participant’s blood pressure is outside the allowable range, 2 additional recordings are allowed each after an additional approximately 5 minutes rest. d. Any abnormal ECG findings as determined by the central reader and confirmed as clinically significant by the Investigator in consultation with the contract research organization (CRO)’s Medical Monitor.","principalExclusionCriteriaTranslations":[{"id":10549676,"uuid":"010e9743-230b-4e4b-8f35-14514c700753","attributeTranslation":"15. L’une des affections cardiovasculaires suivantes : a. Antécédents d’arythmie cliniquement significative (par ex., syndrome du QT long) ; valvulopathie ; hypertension pulmonaire; traitement ou hospitalisation pour un événement cardiovasculaire majeur (par ex., infarctus du myocarde, insuffisance cardiaque, AVC) dans l’année précédant la visite de sélection (Visite 1). b. Antécédents familiaux d’arythmie significative ou parent du 1er degré ayant présenté une mort subite inexpliquée à moins de 40 ans ; antécédents d’épisodes de syncope inexpliqués ; hypokaliémie ou hypomagnésémie non contrôlée. c. Hypertension non contrôlée selon l’investigateur, ou une tension artérielle supérieure à 140 mmHg pour la systolique ou 90 mmHg pour la diastolique lors de la visite de sélection,0 après environ 5 minutes de repos.\nREMARQUE : cette population peut éprouver de l’anxiété en milieu médical. Si la première mesure de la tension artérielle d’un participant se situe en dehors de la plage autorisée, deux mesures supplémentaires sont autorisées, chacune après un repos supplémentaire d’environ 5 minutes. d. Tout résultat anormal à l' ECG tel que déterminé par le lecteur central et confirmé comme cliniquement significatif par l’investigateur en consultation avec le moniteur médical de l’organisme de recherche sous contrat (ORC).","language":34,"languageDescription":"French (France)"},{"id":10549677,"uuid":"010e9743-230b-4e4b-8f35-14514c700753","attributeTranslation":"15. Dowolna z następujących chorób układu krążenia: a. Stwierdzone w wywiadzie klinicznie istotne zaburzenia rytmu serca (np. zespół wydłużonego QT); zastawkowa choroba serca; nadciśnienie płucne; leczenie lub hospitalizacja z powodu poważnego zdarzenia kardiologicznego (np. zawał mięśnia sercowego, niewydolność serca, udar mózgu) w ciągu 1 roku przed badaniem przesiewowym (wizyta 1). b. Istotne zaburzenia rytmu serca lub arytmia pierwszego stopnia u krewnego pierwszego stopnia, u którego nastąpił nagły, niewyjaśniony zgon w wieku poniżej 40 lat; niewyjaśnione epizody omdlenia w wywiadzie; niekontrolowana hipokaliemia lub hipomagnezemia. c. Niekontrolowane nadciśnienie zdaniem badacza lub wartość ciśnienia krwi mierzona po około 5 minutach spoczynku podczas wizyty przesiewowej na poziomie powyżej 140 mmHg dla ciśnienia skurczowego lub 90 mmHg dla ciśnienia rozkurczowego.\nUWAGA: U osób z tej populacji przebywanie w ośrodku medycznym może wywoływać niepokój. Jeśli pierwszy pomiar ciśnienia krwi uczestnika będzie wykraczał poza dozwolony zakres, można wykonać 2 dodatkowe pomiary, przy czym każdy powinien zostać przeprowadzony po około 5 minutach spoczynku. d. Wszelkie nieprawidłowe wyniki badania EKG stwierdzone przez centralnego specjalistę i potwierdzone jako klinicznie istotne przez badacza w porozumieniu z monitorem badania ze strony organizacji prowadzącej badania kliniczne na zlecenie (CRO).","language":19,"languageDescription":"Polish"}]},{"id":1468061,"number":16,"principalExclusionCriteria":"16. One or more laboratory values outside the normal range at Screening (that are considered by the Investigator to be clinically significant). Has any of the following values at Screening or Baseline: a. Serum creatinine value >1.5 x the upper limits of normal (ULN), b. Serum total bilirubin value >1.5 x ULN, c. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 x ULN.","principalExclusionCriteriaTranslations":[{"id":10549678,"uuid":"5b7a345f-3bec-468a-93f5-15803f241a6e","attributeTranslation":"16. Une ou plusieurs valeurs de laboratoire en dehors de la plage normale à la visite de sélection (qui sont considérées par l’investigateur comme étant cliniquement significatives). Présente l’une des valeurs suivantes à la visite de sélection ou à la visite de référence  : a. Taux de créatinine sérique > 1,5 x la limite supérieure de la normale (LSN), b. Taux de bilirubine totale sérique > 1,5 x LSN, c. Taux d’alanine aminotransférase (ALAT) ou d’aspartate aminotransférase (ASAT) sérique > 2 x LSN.","language":34,"languageDescription":"French (France)"},{"id":10549679,"uuid":"5b7a345f-3bec-468a-93f5-15803f241a6e","attributeTranslation":"16. Jeden lub więcej wyników badań laboratoryjnych wykraczających poza zakres normy podczas badań przesiewowych (które są uznawane przez badacza za klinicznie istotne); występowanie którejkolwiek z następujących wartości podczas badań przesiewowych  lub w punkcie wyjściowym: \na. Stężenie kreatyniny w surowicy > 1,5 × górna granica normy (GGN), \nb. Stężenie bilirubiny całkowitej w surowicy > 1,5 × GGN, \nc. Aktywność aminotransferazy alaninowej (ALT) lub aminotransferazy asparaginianowej (AST) w surowicy > 2 × GGN.","language":19,"languageDescription":"Polish"}]},{"id":1468062,"number":17,"principalExclusionCriteria":"17. Has risk of (CCI) based upon medical history or has active (CCI) from 6 months prior to Screening and up to Randomization, as defined by a “Yes” response to (CCI).","principalExclusionCriteriaTranslations":[{"id":10549681,"uuid":"c8f8b9b7-476e-4003-a51b-4f11def12488","attributeTranslation":"17. Ryzyko (CCI) na podstawie wywiadu medycznego lub aktywne (CCI) od 6 miesięcy przed badaniami przesiewowymi i do randomizacji, zdefiniowane jako odpowiedź „Tak” (CCI).","language":19,"languageDescription":"Polish"},{"id":10549680,"uuid":"c8f8b9b7-476e-4003-a51b-4f11def12488","attributeTranslation":"17. Présenter un risque de (CCI) basé sur les antécédents médicaux ou avoir des (CCI) actives dans les 6 mois précédant la visite de sélection et jusqu’à la randomisation, tel que défini par une réponse « Oui » à (CCI).","language":34,"languageDescription":"French (France)"}]},{"id":1468063,"number":18,"principalExclusionCriteria":"18. Has either (CCI) or been hospitalized due to (CCI) within 5 years prior to Screening and up to Randomization as defined by medical history of (CCI) or a “Yes” response in the following (CCI).","principalExclusionCriteriaTranslations":[{"id":10549682,"uuid":"04744598-ea3a-418d-b9e6-9a63d82d6aa5","attributeTranslation":"18. (CCI) lub hospitalizacja z powodu (CCI) w ciągu 5 lat przed badaniem przesiewowym i do randomizacji, zgodnie z definicją przebytych w przeszłości (CCI) lub odpowiedź „Tak” w następujących (CCI).","language":19,"languageDescription":"Polish"},{"id":10549683,"uuid":"04744598-ea3a-418d-b9e6-9a63d82d6aa5","attributeTranslation":"18. Avoir (CCI) ou avoir été hospitalisé en raison d’un (CCI) dans les 5 ans précédant la visite de sélection et jusqu’à la randomisation, tel que défini par les antécédents médicaux de (CCI) ou une réponse « Oui » dans les (CCI) suivantes.","language":34,"languageDescription":"French (France)"}]},{"id":1468064,"number":19,"principalExclusionCriteria":"19. Treatment with deep brain stimulation (DBS), vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) within 6 months prior to Screening or plan to receive treatment with any of these from the time of providing informed consent through End of Study (EOS).","principalExclusionCriteriaTranslations":[{"id":10549685,"uuid":"db9ab58a-eb16-4683-b53f-519897b674d4","attributeTranslation":"19. Głęboka stymulacja mózgu (DBS), stymulacja nerwu błędnego (VNS), elektrowstrząsy (EKT) lub przezczaszkowa stymulacja magnetyczna (TMS) w ciągu 6 miesięcy przed badaniami przesiewowymi lub planowane poddanie się leczeniu którąkolwiek z tych metod od momentu udzielenia świadomej zgody do zakończenia badania (EOS).","language":19,"languageDescription":"Polish"},{"id":10549684,"uuid":"db9ab58a-eb16-4683-b53f-519897b674d4","attributeTranslation":"19. Traitement par stimulation cérébrale profonde (SCP), stimulation du nerf vague (SNV), électroconvulsivothérapie (ECT), ou stimulation magnétique transcrânienne (SMT) dans les 6 mois précédant la visite de sélection ou traitement prévu par l’une de ces modalités à partir du moment où le consentement éclairé est accordé jusqu’à la fin de l’étude (FDE).","language":34,"languageDescription":"French (France)"}]},{"id":1468065,"number":2,"principalExclusionCriteria":"2. First-degree relative with or personal lifetime history of a psychotic disorder (eg, schizophrenia, schizoaffective disorder, etc) or bipolar disorder based on the MINI and/or the psychiatric evaluation.","principalExclusionCriteriaTranslations":[{"id":10549686,"uuid":"2a918567-c329-436d-9ee7-286a5125726a","attributeTranslation":"2. Parent au premier degré ayant ou ayant eu au cours de sa vie des antécédents personnels de trouble psychotique (par ex., schizophrénie, trouble schizoaffectif, etc.) ou trouble bipolaire selon le MINI et/ou l’évaluation psychiatrique.","language":34,"languageDescription":"French (France)"},{"id":10549687,"uuid":"2a918567-c329-436d-9ee7-286a5125726a","attributeTranslation":"2. Krewny pierwszego stopnia z zaburzeniem psychotycznym w wywiadzie osobistym lub w ciągu całego życia (np. schizofrenia, zaburzenia schizoafektywne itp.) bądź chorobą afektywną dwubiegunową na podstawie oceny MINI i/lub oceny psychiatrycznej.","language":19,"languageDescription":"Polish"}]},{"id":1468066,"number":20,"principalExclusionCriteria":"20. History of ketamine/esketamine use within the past (CCI) before Screening (including as part of a clinical study); or use of ketamine for treatment of an excluded condition.","principalExclusionCriteriaTranslations":[{"id":10549689,"uuid":"200c7896-a041-43c5-bcfb-0550a6459c72","attributeTranslation":"20. Stosowanie ketaminy/esketaminy w wywiadzie w ciągu ostatnich (CCI) przed badaniami przesiewowymi (w tym w ramach badania) lub stosowanie ketaminy w terapii wykluczonego schorzenia.","language":19,"languageDescription":"Polish"},{"id":10549688,"uuid":"200c7896-a041-43c5-bcfb-0550a6459c72","attributeTranslation":"20. Antécédents d’utilisation de kétamine/d’eskétamine au cours des (CCI) précédant la visite de sélection (y compris dans le cadre d’une étude clinique) ; ou utilisation de kétamine pour le traitement d’une affection exclue.","language":34,"languageDescription":"French (France)"}]},{"id":1468067,"number":21,"principalExclusionCriteria":"21. Initiated systematic psychotherapy within 4 weeks prior to Screening (Visit 1) or plans to initiate such therapy during the double-blind treatment period.","principalExclusionCriteriaTranslations":[{"id":10549690,"uuid":"f23db5cc-9966-47a9-b2e5-7e1305dabfab","attributeTranslation":"21. Avoir commencé une psychothérapie systémique dans les 4 semaines précédant la visite de sélection (Visite 1) ou prévoir de suivre une telle thérapie pendant la période de traitement en double aveugle.","language":34,"languageDescription":"French (France)"},{"id":10549691,"uuid":"f23db5cc-9966-47a9-b2e5-7e1305dabfab","attributeTranslation":"21. Rozpoczęcie systematycznej psychoterapii w ciągu 4 tygodni przed wizytą przesiewową (wizyta 1) lub planowane rozpoczęcie takiej terapii w okresie leczenia prowadzonego metodą podwójnie ślepej próby.","language":19,"languageDescription":"Polish"}]},{"id":1468068,"number":22,"principalExclusionCriteria":"22. Unwillingness or inability to discontinue prohibited concomitant medications, supplements, or other therapeutics (prescription or over-the-counter) including (CCI). Note: See Section 9.8 of the protocol for details of prohibited concomitant medications, supplements and other therapeutics, and allowable conditions of use. Participants may not discontinue standard of care medication if the purpose of the change is solely to enroll in the study and not medically indicated.","principalExclusionCriteriaTranslations":[{"id":10549692,"uuid":"8e4c485c-f651-49c6-961a-b5daec6286cb","attributeTranslation":"22. Niechęć lub niezdolność do przerwania przyjmowania niedozwolonych leków towarzyszących, suplementów lub innych leków (na receptę lub bez recepty), w tym (CCI). \nUwaga: Szczegółowe informacje na temat zabronionych leków towarzyszących, suplementów i innych leków oraz na temat dopuszczalnych warunków ich stosowania znajdują się w punkcie 9.8 protokołu. Uczestnicy nie mogą odstawiać leczenie standardowego, jeśli powodem takiej decyzji nie są wskazania medyczne, a jedynie chęć włączenia do badania.","language":19,"languageDescription":"Polish"},{"id":10549693,"uuid":"8e4c485c-f651-49c6-961a-b5daec6286cb","attributeTranslation":"22. Refus ou impossibilité d’interrompre les traitements concomitants, les compléments alimentaires ou autres traitements proscrits (sur ordonnance ou en vente libre), y compris (CCI).\nRemarque : voir la section 9.8 du protocole pour plus de détails sur les médicaments concomitants, compléments alimentaires et autres traitements proscrits, et sur les conditions d’utilisation autorisées. Les participants ne peuvent pas interrompre leur traitement habituel si cette interruption a pour seul but de participer à l’étude et si elle n’est pas médicalement indiquée.","language":34,"languageDescription":"French (France)"}]},{"id":1468069,"number":23,"principalExclusionCriteria":"23. (CCI) use of psychedelics, including use as part of a clinical study.","principalExclusionCriteriaTranslations":[{"id":10549695,"uuid":"e0677f3d-65c3-4cb8-b524-b3fcc0aa2873","attributeTranslation":"23. (CCI) utilisation de psychédélique (CCI), y compris l’utilisation dans le cadre d’une étude clinique.","language":34,"languageDescription":"French (France)"},{"id":10549694,"uuid":"e0677f3d-65c3-4cb8-b524-b3fcc0aa2873","attributeTranslation":"23. (CCI) stosowania psychodelików, w tym w ramach badania klinicznego.","language":19,"languageDescription":"Polish"}]},{"id":1468070,"number":24,"principalExclusionCriteria":"24. Any chronic medication that is not expected to remain stable throughout at least the end of the double-blind period or has not been stable for at least 4 weeks prior to Screening. Note: Adjustments to chronic medication may be allowed on a case-by-case basis during the OLE.","principalExclusionCriteriaTranslations":[{"id":10549696,"uuid":"b8b8ba0c-2f40-4431-8c79-d2b72452d1bb","attributeTranslation":"24. Wszelkie leki przyjmowane przewlekle, co do których nie oczekuje się, że ich dawka pozostanie stabilna przez co najmniej cały okres trwania badania prowadzonego metodą podwójnie ślepej próby lub dawka nie była stabilna przez co najmniej 4 tygodnie przed badaniem przesiewowym. Uwaga: Dostosowanie dawki przyjmowanych leków przewlekłych może być dozwolone w wypadku poszczególnych uczestników w trakcie badania prowadzonego metodą otwartej próby.","language":19,"languageDescription":"Polish"},{"id":10549697,"uuid":"b8b8ba0c-2f40-4431-8c79-d2b72452d1bb","attributeTranslation":"24. Tout traitement médicamenteux chronique dont on ne s’attend pas à ce qu’il reste stable au moins jusqu’à la fin de la période en double aveugle ou qui n’a pas été stable pendant au moins 4 semaines avant la visite de sélection. Remarque : un ajustement des traitements médicamenteux chroniques peut être autorisé au cas par cas pendant la période d’extension en ouvert.","language":34,"languageDescription":"French (France)"}]},{"id":1468071,"number":25,"principalExclusionCriteria":"25. Previous or current participation in any MM120 study.","principalExclusionCriteriaTranslations":[{"id":10549699,"uuid":"2d036a82-e141-4427-9ca0-4f6a3930a968","attributeTranslation":"25. Wcześniejszy lub obecny udział w dowolnym badaniu MM120.","language":19,"languageDescription":"Polish"},{"id":10549698,"uuid":"2d036a82-e141-4427-9ca0-4f6a3930a968","attributeTranslation":"25. Participation antérieure ou actuelle à une étude portant sur le MM120.","language":34,"languageDescription":"French (France)"}]},{"id":1468072,"number":26,"principalExclusionCriteria":"26. Previous participation in any clinical study for an investigational drug, device, or therapy within 6 months of Screening and throughout the duration of this study.","principalExclusionCriteriaTranslations":[{"id":10549700,"uuid":"4e02099e-ffc4-4fea-82b3-152520ed75a0","attributeTranslation":"26. Wcześniejszy udział w jakimkolwiek badaniu klinicznym  nad lekiem eksperymentalnym, urządzeniem lub terapią w ciągu 6 miesięcy przed badaniami przesiewowymi i przez cały czas trwania tego badania.","language":19,"languageDescription":"Polish"},{"id":10549701,"uuid":"4e02099e-ffc4-4fea-82b3-152520ed75a0","attributeTranslation":"26. Participation antérieure à une étude clinique portant sur un médicament, un dispositif ou un traitement dans les 6 mois précédant la visite de sélection et pendant toute la durée de cette étude.","language":34,"languageDescription":"French (France)"}]},{"id":1468073,"number":27,"principalExclusionCriteria":"27. Positive urine drug screen (UDS) for substances of abuse at Screening, Baseline, or Randomization. Note: Participants with a positive urine drug screen for cannabis or benzodiazepines or other prescribed medications at Screening may be eligible if they discontinue use and washout during the Screening period, if applicable.","principalExclusionCriteriaTranslations":[{"id":10549702,"uuid":"c43c4b7d-c53d-44b3-9443-f994091ebbe6","attributeTranslation":"27. Test de dépistage urinaire de drogues (urine drug screen, UDS) positif pour les substances d’abus à la visite de sélection, à la visite de référence ou au moment de la randomisation. Remarque : les participants présentant un test de dépistage urinaire de drogues positif pour le cannabis, les benzodiazépines ou d’autres médicaments prescrits à la visite de sélection peuvent être éligibles s’ils interrompent leur utilisation et se prêtent à un sevrage pendant la période de sélection, le cas échéant.","language":34,"languageDescription":"French (France)"},{"id":10549703,"uuid":"c43c4b7d-c53d-44b3-9443-f994091ebbe6","attributeTranslation":"27. Dodatni wynik badania przesiewowego moczu na obecność narkotyków (UDS) pod kątem substancji uzależniających podczas wizyty przesiewowej, wyjściowej lub randomizacji. Uwaga: Uczestnicy z dodatnim wynikiem badania przesiewowego moczu na obecność narkotyków w kierunku marihuany lub benzodiazepin lub innych przepisanych leków podczas badań przesiewowych mogą kwalifikować się do udziału w badaniu, jeżeli przerwą stosowanie i przejdą i wypłukiwanie w okresie badań przesiewowych, jeśli dotyczy.","language":19,"languageDescription":"Polish"}]},{"id":1468074,"number":28,"principalExclusionCriteria":"28. Women who are currently pregnant or breastfeeding or plan to become pregnant during the study.","principalExclusionCriteriaTranslations":[{"id":10549704,"uuid":"51799950-5253-41f5-ae47-d5bd5f55460f","attributeTranslation":"28. Femmes actuellement enceintes ou allaitantes ou qui prévoient de débuter une grossesse pendant l’étude.","language":34,"languageDescription":"French (France)"},{"id":10549705,"uuid":"51799950-5253-41f5-ae47-d5bd5f55460f","attributeTranslation":"28. Kobiety w ciąży, karmiące piersią lub planujące zajść w ciążę w trakcie badania.","language":19,"languageDescription":"Polish"}]},{"id":1468075,"number":29,"principalExclusionCriteria":"29. Participants who plan to donate sperm or eggs during the study, or who plan to donate sperm within 90 days or eggs within 30 days, respectively, after their last MM120 dose..","principalExclusionCriteriaTranslations":[{"id":10549707,"uuid":"18ca2761-18e4-45b4-a2e2-daac768c656b","attributeTranslation":"29. Uczestnicy, którzy planują oddanie nasienia lub komórek jajowych w trakcie badania lub którzy planują oddanie nasienia w ciągu 90 dni lub komórek jajowych w ciągu 30 dni od przyjęcia ostatniej dawki MM120.","language":19,"languageDescription":"Polish"},{"id":10549706,"uuid":"18ca2761-18e4-45b4-a2e2-daac768c656b","attributeTranslation":"29. Participants qui prévoient de faire un don de sperme ou d’ovules pendant l’étude, ou qui prévoient de faire un don de sperme dans les 90 jours ou de faire un don d’ovules dans les 30 jours, respectivement, après leur dernière dose de MM120.","language":34,"languageDescription":"French (France)"}]},{"id":1468076,"number":3,"principalExclusionCriteria":"3. Personal lifetime history of bipolar disorder I or II, post-traumatic stress disorder, or a personality disorder, based on the MINI and/or the psychiatric evaluation.","principalExclusionCriteriaTranslations":[{"id":10549709,"uuid":"3e851b08-9fa9-4974-b49c-2937eb499b1c","attributeTranslation":"3. Osobista historia choroby afektywnej dwubiegunowej i lub II, zespół stresu pourazowego lub zaburzenia osobowości, na podstawie oceny MINI i/lub oceny psychiatrycznej.","language":19,"languageDescription":"Polish"},{"id":10549708,"uuid":"3e851b08-9fa9-4974-b49c-2937eb499b1c","attributeTranslation":"3. Antécédents personnels de trouble bipolaire de type I ou II, de trouble du stress post-traumatique ou de trouble de la personnalité, selon le MINI et/ou l’évaluation psychiatrique.","language":34,"languageDescription":"French (France)"}]},{"id":1468077,"number":4,"principalExclusionCriteria":"4. Current psychiatric disorder that, in the opinion of the Investigator, is symptomatic in a manner that may confound the results of the study (eg, MDD, obsessive-compulsive disorder, dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa, or bulimia nervosa).","principalExclusionCriteriaTranslations":[{"id":10549711,"uuid":"941d6264-0ed9-4028-a92d-c13ce8cf59d3","attributeTranslation":"4. Trouble psychiatrique actuel qui, de l’avis de l’investigateur, est symptomatique d’une manière qui peut\nfausser les résultats de l’étude (par ex., TDM, trouble obsessionnel compulsif, trouble dysthymique, trouble panique, trouble dissociatif, anorexie mentale ou boulimie mentale).","language":34,"languageDescription":"French (France)"},{"id":10549710,"uuid":"941d6264-0ed9-4028-a92d-c13ce8cf59d3","attributeTranslation":"4. Występujące obecnie zaburzenia psychiczne, które zdaniem badacza przebiegają z objawami w sposób, który może zakłócić wyniki badania (np. MDD, zaburzenia obsesyjno-kompulsywne, dystymia, lęk napadowy, zaburzenia dysocjacyjne, jadłowstręt lub bulimia).","language":19,"languageDescription":"Polish"}]},{"id":1468078,"number":5,"principalExclusionCriteria":"5. Lifetime diagnosis of substance use disorder (excluding nicotine and caffeine), current diagnosis of alcohol use disorder,  or treatment for alcohol or substance use disorder within (CCI) prior to Screening (Visit 1) as assessed by the MINI.","principalExclusionCriteriaTranslations":[{"id":10549712,"uuid":"2a012bb8-30d5-47b7-8c97-a0faf5205eff","attributeTranslation":"5. Rozpoznanie w dowolnym momencie życia zaburzeń związanych z zażywaniem substancji psychoaktywnych (z wyłączeniem nikotyny i kofeiny), aktualne rozpoznanie zaburzeń związanych z nadużywaniem alkoholu lub leczenie zaburzeń związanych z nadużywaniem alkoholu lub zażywaniem substancji psychoaktywnych w ciągu (CCI) przed wizytą przesiewową (wizyta 1), na podstawie MINI.","language":19,"languageDescription":"Polish"},{"id":10549713,"uuid":"2a012bb8-30d5-47b7-8c97-a0faf5205eff","attributeTranslation":"5. Antécédents de trouble lié à l’usage de substances (à l’exclusion de la nicotine et de la caféine), diagnostic actuel d’alcoolisme ou traitement pour alcoolisme ou trouble lié à l’usage de substances dans les (CCI) précédant la visite de sélection (Visite 1) tel qu’évalué par le MINI.","language":34,"languageDescription":"French (France)"}]},{"id":1468079,"number":6,"principalExclusionCriteria":"6. Current diagnosis or history of neurological disorders including seizures (except febrile resolved before age 5): neurodevelopmental disorders (eg, autism spectrum disorder [ASD]), neurodegenerative disorders; movement disorders, traumatic brain injury (long-term impairment, currently symptomatic or in treatment), or any central nervous system (CNS) vascular disorders (eg, cerebral ischemia, aneurysm, or arteriovenous malformation)..","principalExclusionCriteriaTranslations":[{"id":10549714,"uuid":"b988e3c3-0c1f-40de-8fbf-862b80308961","attributeTranslation":"6. Aktualne rozpoznanie lub zaburzenia neurologiczne w wywiadzie, w tym napady drgawkowe (z wyjątkiem gorączkowych, które ustąpiły przed wiekiem 5 lat): zaburzenie neurorozowojowe [np. zaburzenia ze spektrum autyzmu (ASD)]; zaburzenia neurodegeneracyjne; zaburzenia ruchowe, urazowe uszkodzenie mózgu (długotrwałe upośledzenie, obecnie objawowe lub w trakcie leczenia) lub dowolne zaburzenia naczyniowe w ośrodkowym układzie nerwowym (OUN) (np. niedokrwienie, tętniak lub malformacja tętniczo-żylna mózgu).","language":19,"languageDescription":"Polish"},{"id":10549715,"uuid":"b988e3c3-0c1f-40de-8fbf-862b80308961","attributeTranslation":"6. Diagnostic actuel ou antécédents de troubles neurologiques, y compris crises convulsives (à l’exception des crises fébriles résolues avant l’âge de 5 ans) : troubles neurodéveloppementaux (par ex. trouble du spectre de l’autisme [TSA]), troubles neurodégénératifs ; mouvements anormaux, traumatisme crânien  (déficience à long terme, actuellement symptomatique ou en traitement) ou tout trouble vasculaire du système nerveux central (SNC) (par ex. ischémie cérébrale, anévrisme ou malformation artérioveineuse).","language":34,"languageDescription":"French (France)"}]},{"id":1468080,"number":7,"principalExclusionCriteria":"7. Any clinically significant unstable illness. For example, hepatic impairment, renal insufficiency, gastrointestinal, cardiovascular, pulmonary, musculoskeletal, immunologic, endocrine, or metabolic disease that, in the opinion of the Investigator, may pose a risk to participation or confound the results of the study.","principalExclusionCriteriaTranslations":[{"id":10549717,"uuid":"33885b6e-2e43-4a3d-af01-eb17aa9f18ed","attributeTranslation":"7. Wszelkie klinicznie istotne niestabilne choroby. Na przykład zaburzenia czynności wątroby, niewydolność nerek, choroba układu pokarmowego, układu krążenia, płuc, układu mięśniowo-szkieletowego, choroby immunologiczne, endokrynologiczne lub metaboliczne, które zdaniem badacza mogą stwarzać ryzyko dla udziału w badaniu lub zakłócać wyniki badania.","language":19,"languageDescription":"Polish"},{"id":10549716,"uuid":"33885b6e-2e43-4a3d-af01-eb17aa9f18ed","attributeTranslation":"7. Toute maladie instable cliniquement significative. Par exemple, insuffisance hépatique, insuffisance rénale,\nmaladie gastro-intestinale, cardiovasculaire, pulmonaire, musculosquelettique, immunologique, endocrinienne ou métabolique qui, de l’avis de l’investigateur, peut présenter un risque pour la participation ou fausser les résultats de l’étude.","language":34,"languageDescription":"French (France)"}]},{"id":1468081,"number":8,"principalExclusionCriteria":"8. Current clinically significant untreated sleep disorder that, in the opinion of the Investigator, may confound the results of the study (eg, obstructive sleep apnea, narcolepsy).","principalExclusionCriteriaTranslations":[{"id":10549719,"uuid":"98bb3215-a42f-43bb-9ea2-51d8a9f9686a","attributeTranslation":"8. Troubles du sommeil non traités cliniquement significatifs actuels qui, de l’avis de l’investigateur, peuvent fausser les résultats de l’étude (par ex., apnée obstructive du sommeil, narcolepsie).","language":34,"languageDescription":"French (France)"},{"id":10549718,"uuid":"98bb3215-a42f-43bb-9ea2-51d8a9f9686a","attributeTranslation":"8. Występujące obecnie klinicznie istotne, nieleczone zaburzenia snu, które zdaniem badacza mogą zakłócać wyniki badania (np. obturacyjny bezdech senny, narkolepsja).","language":19,"languageDescription":"Polish"}]},{"id":1468082,"number":9,"principalExclusionCriteria":"9. Undiagnosed, untreated, or poorly controlled diabetes, defined as: glycosylated hemoglobin (HbA1C) ≥7% at Screening (Visit 1), without prior intervention. Note: participants with known stable diabetes with HbA1C ≥7% may be eligible if deemed not clinically significant by the Investigator.","principalExclusionCriteriaTranslations":[{"id":10549721,"uuid":"3952d73e-a442-49a9-9181-441a4fc091af","attributeTranslation":"9. Nierozpoznana, nieleczona lub słabo kontrolowana cukrzyca, zdefiniowana jako: stężenie hemoglobiny glikozylowanej (HbA1C) ≥7% w badaniu przesiewowym (wizyta 1), bez wcześniejszej interwencji. Uwaga: uczestnicy ze stabilną cukrzycą ze stężeniem HbA1C ≥7% mogą kwalifikować się do udziału w badaniu, jeżeli badacz uzna, że nie jest to klinicznie istotne.","language":19,"languageDescription":"Polish"},{"id":10549720,"uuid":"3952d73e-a442-49a9-9181-441a4fc091af","attributeTranslation":"9. Diabète non diagnostiqué, non traité ou mal contrôlé, défini comme : hémoglobine glyquée (HbA1C) ≥ 7 % à\nla visite de sélection (Visite 1), sans intervention préalable. Remarque : les participants présentant un diabète stable connu avec un HbA1C ≥ 7 % peuvent être éligibles si l’investigateur estime que cela n’est pas cliniquement significatif.","language":34,"languageDescription":"French (France)"}]}]},"endPoint":{"primaryEndPoints":[{"id":1005050,"number":1,"endPoint":"Double-blind Period (Part A): Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12.","isPrimary":true,"endPointTranslations":[{"id":10549649,"uuid":"d621d2f3-51b3-4979-bb3f-203fff3d6a15","attributeTranslation":"Période en double aveugle (Partie A) : variation par rapport à la visite de référence du score total sur l’échelle d’évaluation de l’anxiété de Hamilton (HAM-A) à la Semaine 12.","language":34,"languageDescription":"French (France)"},{"id":10549648,"uuid":"d621d2f3-51b3-4979-bb3f-203fff3d6a15","attributeTranslation":"Etap badania prowadzony metodą podwójnie ślepej próby (Część A): Zmiana w stosunku do punktu wyjściowego w łącznym wyniku skali oceny lęku Hamiltona (HAM-A) w tygodniu 12.","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":1005051,"number":1,"endPoint":"Double-blind Period (Part A): Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1. HAM-A response/remission at each timepoint assessed during 12-week double-blind period. A full description of this endpoint can be found in the protocol.","isPrimary":false,"endPointTranslations":[{"id":10549650,"uuid":"f4c2d196-b47e-47d1-9a5b-ccc67b4c7bc6","attributeTranslation":"1. Etap badania prowadzony metodą podwójnie ślepej próby(Część A):Zmiana w stosunku do punktu wyjściowego w całkowitym wyniku HAM-A w tygodniu 8, 4, 2 i tygodniu 1. Odpowiedź/remisja HAM-A w każdym punkcie czasowym oceniana podczas 12-tygodniowego okresu prowadzonego metodą podwójnie ślepej próby. Wynik w skali CGI-I w każdym punkcie czasowym oceniany podczas 12-tygodniowego okresu prowadzonego metodą podwójnie ślepej próby. Pełny opis tego punktu końcowego można znaleźć w protokole.","language":19,"languageDescription":"Polish"},{"id":10549651,"uuid":"f4c2d196-b47e-47d1-9a5b-ccc67b4c7bc6","attributeTranslation":"1. Période en double aveugle (Partie A) : variation par rapport à la visite de référence du score total HAM-A à la Semaine 8, 4, 2 et à la Semaine 1. Réponse/rémission selon le score HAM-A à chaque point temporel évalué pendant la période en double aveugle de 12 semaines. Score sur l’échelle CGI-I à chaque point temporel évalué pendant la période en double aveugle de 12 semaines. Une description complète de ce critère se trouve dans le protocole.","language":34,"languageDescription":"French (France)"}]},{"id":1005052,"number":2,"endPoint":"Open-label Extension (Part B): HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40 week open-label period. A full description of this endpoint can be found in the protocol.","isPrimary":false,"endPointTranslations":[{"id":10549653,"uuid":"3bb60816-354f-4bea-891c-e00282a61a78","attributeTranslation":"2. Période d’extension en ouvert (Partie B) : réponse selon le score HAM-A (réduction par rapport au score de référence ≥ 50 %) à chaque point temporel évalué pendant la période en ouvert de 40 semaines.  Une description complète de ce critère se trouve dans le protocole.","language":34,"languageDescription":"French (France)"},{"id":10549652,"uuid":"3bb60816-354f-4bea-891c-e00282a61a78","attributeTranslation":"2. Badanie kontynuacyjne prowadzone metodą otwartej próby (Część B): odpowiedź HAM-A (obniżenie o ≥50% względem wyniku wyjściowego) w każdym punkcie czasowym w okresie trwającego 40 tygodni leczenia prowadzonego metodą otwartej próby.","language":19,"languageDescription":"Polish"}]},{"id":1005053,"number":3,"endPoint":"Open label extension (Part B): Change from Double-blind Baseline at each timepoint assessed during the 40-week open-label period in the following: • HAM-A/ MADRS total score • CGI-S/ PGI-S Scale score • WPAI • EQ-5D-5L.","isPrimary":false,"endPointTranslations":[{"id":10549654,"uuid":"7b28b163-cd63-403a-b4e9-660de596d338","attributeTranslation":"3. Badanie kontynuacyjne prowadzone metodą otwartej próby (Część B): Zmiana w stosunku do punktu wyjściowego badania prowadzonego metodą podwójnie ślepej próby w każdym punkcie czasowym ocenianym podczas 40-tygodniowego okresu prowadzonego metodą otwartej próby jako następujące parametry: • całkowity wynik w skali HAM-A/MADRS • wynik w skali CGI-S/PGI-S • WPAI • EQ-5D-5L.","language":19,"languageDescription":"Polish"},{"id":10549655,"uuid":"7b28b163-cd63-403a-b4e9-660de596d338","attributeTranslation":"3. Période d’extension en ouvert (Partie B) : variation par rapport à visite de référence de la période en double aveugle à chaque point temporel évalué pendant la période en ouvert de 40 semaines pour ce qui suit : • Score total HAM-A/MADRS • Score sur l’échelle CGI-S/PGI-S • WPAI • EQ-5D-5L.","language":34,"languageDescription":"French (France)"}]},{"id":1005054,"number":4,"endPoint":"Open label extension (Part B): CSFQ-14 total score at each timepoint assessed during the open-label period. Percent of  men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period.","isPrimary":false,"endPointTranslations":[{"id":10549656,"uuid":"97fd2ce9-22b0-4ea5-92a4-3b355937ed94","attributeTranslation":"4. Période d’extension en ouvert (Partie B) : score total CSFQ-14 à chaque point temporel évalué pendant la période en ouvert. Pourcentage d’hommes et de femmes ayant un fonctionnement sexuel normal et anormal à chaque point temporel évalué pendant la période en ouvert.","language":34,"languageDescription":"French (France)"},{"id":10549657,"uuid":"97fd2ce9-22b0-4ea5-92a4-3b355937ed94","attributeTranslation":"4. Badanie kontynuacyjne prowadzone metodą otwartej próby (Część B): Łączny wynik CSFQ-14 w każdym punkcie czasowym ocenianym w okresie prowadzonym metodą otwartej próby. Odsetek mężczyzn i kobiet z prawidłowym i zaburzonym życiem seksualnym w każdym punkcie czasowym ocenianym w okresie prowadzonym metodą otwartej próby.","language":19,"languageDescription":"Polish"}]},{"id":1005055,"number":5,"endPoint":"Double-blind Period (Part A) key secondary: Change from Baseline to Week 12 in CGI-S scale score, to Week 1 in HAM-A total score, to Day 2 in CGI-S score.","isPrimary":false,"endPointTranslations":[{"id":10549659,"uuid":"dd16756e-4a3f-4961-960d-9866b59f9eed","attributeTranslation":"5. Etap badania prowadzony metodą podwójnie ślepej próby (Część A)– kluczowy drugorzędowy: Zmiana w stosunku do punktu wyjściowego  wyniku w skali CGI-S w tygodniu 12, łącznego wyniku w skali HAM-A w tygodniu 1,  wyniku w skali CGI-S w dniu 2.","language":19,"languageDescription":"Polish"},{"id":10549658,"uuid":"dd16756e-4a3f-4961-960d-9866b59f9eed","attributeTranslation":"5. Critère secondaire clé de la période en double aveugle (Partie  A): variation par rapport à la visite de référence du score sur l’échelle CGI-S à la Semaine 12, du score total HAM-A à la Semaine 1, du score CGI-S au Jour 2. Délai jusqu’au premier retraitement ou manque d’efficacité.","language":34,"languageDescription":"French (France)"}]},{"id":1005056,"number":6,"endPoint":"Part A and B: Percent of participants requiring 1, 2, 3, 4, or 5 doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period. Need for MM120 treatment as assessed by the average number of MM120 treatments received.","isPrimary":false,"endPointTranslations":[{"id":10549660,"uuid":"3c97ecc5-766d-471a-b234-26d1b59eac5a","attributeTranslation":"6. Części A i B: odsetek uczestników wymagających 1, 2, 3, 4 lub 5 dawek MM120 w ciągu 52 tygodni badania (części A i B) w ocenie uczestników spełniających określone w protokole kryteria ponownego zastosowania leku w okresie trwającego 40 tygodni okresu leczenia metodą otwartej próby. Potrzeba zastosowania MM120 oceniana jako średnia liczba zastosowań MM120.","language":19,"languageDescription":"Polish"},{"id":10549661,"uuid":"3c97ecc5-766d-471a-b234-26d1b59eac5a","attributeTranslation":"6. Parties A et B : pourcentage de participants nécessitant 1, 2, 3, 4 ou 5 doses de MM120 pendant l’étude de 52 semaines (Partie A et Partie B), tel qu’évalué par les participants remplissant les critères de retraitement spécifiés par le protocole pendant la période en ouvert de 40 semaines. Besoin de traitement par MM120 évalué par le nombre moyen de traitements par MM120 reçus.","language":34,"languageDescription":"French (France)"}]},{"id":1005057,"number":7,"endPoint":"Part A and B: Single dose durability as assessed by time to event where (CCI) GAD symptoms resurfaced (see details in the Statistical Analysis Plan [SAP]). Time from first dose (Part A) to first retreatment in the open-label period (Part B)","isPrimary":false,"endPointTranslations":[{"id":10549662,"uuid":"66960f21-aec0-424f-afe5-f3856d781b75","attributeTranslation":"7. Części A i B: trwałość pojedynczej dawki oceniana jako czas do zdarzenia ponownego pojawienia się objawów GAD (CCI) [por. szczegółowy opis w Planie analiz statystycznych (SAP)]. Czas od podania pierwszej dawki (część A) do pierwszego ponownego podania w okresie prowadzonym metodą otwartej próby (część B).","language":19,"languageDescription":"Polish"},{"id":10549663,"uuid":"66960f21-aec0-424f-afe5-f3856d781b75","attributeTranslation":"7. Parties A et B : durabilité d’une dose unique, évaluée par le délai écoulé avant la réapparition de symptômes de TAG (CCI) (voir détails dans le plan d’analyse statistique [SAP]). Délai écoulé de la première dose (Partie A) au premier retraitement pendant la période en ouvert (Partie B).","language":34,"languageDescription":"French (France)"}]}]},"trialDuration":{"estimatedGlobalEndDate":"2027-05-25","estimatedEndDate":"2027-05-25","estimatedRecruitmentStartDate":"2025-03-31"},"sourceOfMonetarySupport":[{"id":92944,"organisationName":"Definium Therapeutics US Inc."}],"populationOfTrialSubjects":{"ageRanges":[{"id":348929,"ageRangeCategoryCode":"3","ageRangeCategory":"3"},{"id":348928,"ageRangeCategoryCode":"4","ageRangeCategory":"4"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":true},"individualParticipantData":{"planToShareIPD":"1","planDescription":"Sponsor is committed to sharing individual participant data (IPD) from its clinical studies to promote transparency and facilitate further research. IPD includes anonymized demographic information, clinical assessments, treatment assignments, and patient-reported outcomes. Results of clinical studies will be provided on the publicly funded website ClinicalTrials.gov and the European Union Clinical Trials Register in line with applicable regulations. All data will be anonymized to protect participant confidentiality and comply with regulations. Sponsor commits to sharing upon request from qualified scientific researchers participant-level, study-level clinical study data, and protocol from clinical studies in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. All Sponsor-sponsored clinical studies are considered for publication in the scientific literature regardless of whether the results are positive or negative."}},"protocolInformation":{"studyDesign":{"periodDetails":[{"id":182924,"businessKey":"1","title":"Study design","description":"This is a Phase 3, multicenter, 12-week, randomized, double-blind, placebo-controlled study (Part A) with a 40-week OLE (Part B) assessing the effect of 100 μg MM120 ODT for the treatment of adults with GAD. A 50 μg MM120 group is included to mitigate functional unblinding.\nThe study will enroll up to 375 participants aged 18 years to 74 years, inclusive with a DSM-5 confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychological history.\nThe study consists of, 1) a 12-week randomized, double-blind, single dose administration period evaluating MM120 versus inactive placebo, followed by 2) a 40-week OLE during which participants will be monitored and evaluated for potential retreatment with active MM120 based on pre-specified safety and severity criteria.\nPotential participants will be evaluated at Screening (Visit 1) and those who meet initial entrance criteria will continue with the eligibility process and advance to Baseline (Visit 2). To confirm eligibility a SAFER interview will be conducted remotely by an independent assessor. To confirm eligibility and assess efficacy throughout the study, centralized raters independent of the site will administer the HAM-A. Participants on prohibited medications, who are willing and able, will taper off medications, overseen by the study site prescribing health care provider (HCP) based on acceptable local practice standards.\nRandomization will occur following the final assessment of eligibility on Day 1. Eligible participants will be randomized in a 2:1:2 ratio to receive a single dose of either 100 μg MM120, 50 μg MM120, or matching placebo with Study Site as a randomization stratum. Study drug will be administered in a controlled clinical setting during the Dosing Session on Day 1. In exceptional circumstances and  where the IMP is stored at a location different than the study site, such as hospital pharmacy, participants can be randomized one business day prior to planned dosing. Participants will only be dosed once their eligibility is confirmed.\nPrior to Day 1, participants will meet with their DSMs who will provide education about the study drug and dosing procedures and review study logistics.\nAfter Day 1, participants will have scheduled visits on Day 2, Week 1, Week 2, Week 4, Week 8, and Week 12.\nParticipants who complete the double-blind period will be evaluated for eligibility for continuation into the 40-week OLE. During the open-label period, participants will continue to be assessed for maintenance of efficacy and safety every 4 weeks. In addition, participants will be assessed for potential retreatment during the OLE based on prespecified criteria.Note that participants who received placebo in the double-blind portion will be receiving treatment for the first time in the OLE if they meet HAM-A criterion. The term “retreatment” is used as a general term for any participant meeting criterion for dosing in the OLE.\nRetreatment Assessment during the OLE\nThroughout the study, participants will complete a biweekly self-assessment of anxiety symptoms using the General Anxiety Disorder 7-item (GAD-7). In addition, participants will have HAM-A assessments conducted by the central rater per the Schedule of Assessments (SoA). During the OLE, if self-reported anxiety severity meets the threshold criterion of (CCI) total score on the GAD-7, indicating at least (CCI) anxiety symptoms, the site will be notified. Upon notification, the site will contact the participant and assess if their anxiety level was accurately reported and, if so, request the central rater conduct a HAM-A assessment with the participant. Participants with a HAM-A total score (CCI) may be eligible for retreatment with 100 μg MM120 (open-label). These participants will proceed to the retreatment period assessments beginning with the R1 visit. A full description is provided on the protocol.","blindingMethodCode":"2","blindedRoles":[{"id":182925,"code":1,"name":"Subject"},{"id":182926,"code":4,"name":"Analyst"},{"id":182928,"code":2,"name":"Investigator"},{"id":182927,"code":3,"name":"Monitor"}],"blindingDetails":"All participants will be centrally assigned to randomized study drug in a 2:1:2 ratio using interactive response technology (IRT). To protect against potential variability among study sites, randomization will be stratified by site. Before the study is initiated, information and directions for the IRT will be provided to each site. In the double-blind portion of the study all parties are blinded to study drug during the 12-week randomized, placebo-controlled treatment period. In addition, the primary endpoint HAM-A assessments are conducted by a central rater who is independent of the site, blinded to the treatment and visit number.\n\nNo blinding method is used for the open-label extension","armDetails":[{"description":"MM120 100 μg - Up to 150 subjects","title":"Double-blind period (Part A) - Active","id":102121},{"description":"MM120 50 μg - Up to 75 subjects","title":"Double-blind period (Part A) - Active","id":102122},{"description":"Matching placebo - Up to 150 subjects","title":"Duble-blind period (Part A) - Placebo","id":102123},{"description":"MM120 100 μg","title":"Open-label period (Part B) - Active","id":102124}],"allocationMethod":"1"}]}},"scientificAdviceAndPip":{"scientificAdvices":[{"id":54198,"competentAuthority":{"id":612444,"organisation":{"id":650013,"type":"Non-EEA National Competent authority","typeCode":"17","name":"Food And Drug 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