{"ctNumber":"2024-520171-27-00","ctStatus":"Authorised","startDateEU":"2023-12-18","decisionDate":"2025-01-13T15:19:30.481","publishDate":"2026-08-20T03:35:03.949838414","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":93663,"rowSubjectCount":0,"products":[{"id":385248,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11818432","productPharmForm":"OIL","euMpNumber":"PRD11818432","prodAuthStatus":1,"prodName":"Full spectrum cannabis extract","pharmForm":"OIL","sponsorProductCode":"YCJ-01","activeSubstanceName":"DRONABINOL, CANNABIDIOL","euSubstNumber":"SUB06407MIG","nameOrg":"OILS4CURE S.L.","productSubstances":[{"productPk":"11818432","substancePk":"352044","nameOrg":"OILS4CURE S.L.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"DRONABINOL","substanceEvCode":"SUB06407MIG"},{"productPk":"11818432","substancePk":"337822","nameOrg":"OILS4CURE S.L.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"CANNABIDIOL","substanceEvCode":"SUB26600"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg/kg milligram(s)/kilogram","maxDailyDoseAmount":"12.07","doseUomTotal":"mg/kg milligram(s)/kilogram","maxTotalDoseAmount":"2703.68","maxTreatmentPeriod":8,"timeUnitCode":"3","evCode":"PRD11818432","sponsorProductCodeEdit":"YCJ-01","devices":[],"characteristics":["9"],"routes":["ORAL"],"allSubstancesChemicals":true,"productName":"Full spectrum cannabis extract","jsonActiveSubstanceNames":"dronabinol, cannabidiol","pharmaceuticalFormDisplay":"OIL"},{"id":385247,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo to YCJ-01","pharmForm":"N/A","activeSubstanceName":"N/A","euSubstNumber":"N/A","productOtherName":"N/A","authorisationCountryCode":"IS","nameOrg":"N/A","sponsorSubstanceCode":"N/A","atcCode":"N/A","atcName":"N/A","atcTermLevel":"N/A","activeSubstanceOtherDescriptiveName":"N/A"},"isPaediatricFormulation":false,"mpRoleInTrial":"3","timeUnitCode":"2","evCode":"N/A","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo to YCJ-01","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"Treatment with full-spectrum cannabis extract of refractory epilepsy associated with Tuberous Sclerosis Complex (TSC): SPECTRUM","fullTitleTranslations":[{"id":7294944,"uuid":"51c90002-2241-49d0-ad0e-96b146807655","attributeTranslation":"Tratamiento, con extracto de cannabis de espectro completo, de la epilepsia refractaria asociada a complejo Esclerosis Tuberosa (CET): SPECTRUM","language":7,"languageDescription":"Spanish"}],"publicTitle":"Treatment of difficult-to-control epilepsy associated with tuberous sclerosis complex","publicTitleTranslations":[{"id":7294955,"uuid":"a54b65e0-1a15-4083-9016-301e040bfb27","attributeTranslation":"Tratamiento de la epilepsia de difícil control, asociada a complejo de esclerosis tuberosa","language":7,"languageDescription":"Spanish"}],"shortTitle":"EstuEla2022","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"Therapeutic confirmatory: Phase III trial","trialCategoryId":84553},"medicalCondition":{"partIMedicalConditions":[{"id":96466,"medicalCondition":"Refractory epilepsy in tuberous sclerosis complex","medicalConditionTranslations":[{"id":7294918,"uuid":"d6bcaae9-10c3-424e-83d6-940f24dee2ca","attributeTranslation":"Epilepsia refractaria en Complejo de Esclerosis Tuberosa","language":7,"languageDescription":"Spanish"}],"isConditionRareDisease":true}],"meddraConditionTerms":[{"termId":200000008797,"version":"21.0","level":"PT","termName":"Tuberous sclerosis complex","classificationCode":"10080584","organClass":100000004850,"active":false}]},"trialObjective":{"trialScopes":[{"code":"4","trialScopeId":279237},{"code":"5","trialScopeId":279236},{"code":"9","trialScopeId":279238}],"mainObjective":"1. To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.\n2. To assess the safety of the treatment with YCJ-01 in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex.","mainObjectiveTranslations":[{"id":7294954,"uuid":"e37a5137-0beb-4bcf-a1bf-b9f20569dea1","attributeTranslation":"1. Evaluar la eficacia del tratamiento con YCJ-01 mediante los cambios en el número de crisis epilépticas en pacientes con epilepsia refractaria secundaria a Complejo Esclerosis Tuberosa.\n2. Evaluar la seguridad del tratamiento con YCJ-01 en pacientes con epilepsia refractaria secundaria a Complejo Esclerosis Tuberosa.","language":7,"languageDescription":"Spanish"}],"secondaryObjectives":[{"id":320136,"number":1,"secondaryObjective":"To assess the response rate to YCJ-01/placebo: patients who achieve a decrease in at least a 50 % of the number of epileptic seizures compared to the baseline period (from visit P0 to P1) will be considered responders.","secondaryObjectiveTranslations":[{"id":7294956,"uuid":"0a1cc1de-39a8-4421-a3ec-eaff5a94ccae","attributeTranslation":"Evaluar la tasa de respuesta a YCJ-01/placebo: se considerará respondedores a aquellos pacientes que alcancen  na reducción en el número de crisis epilépticas de al menos un 50% con respecto al período basal (de la visita P0 a la P1).","language":7,"languageDescription":"Spanish"}]},{"id":320137,"number":2,"secondaryObjective":"To assess the proportion of subjects in treatment with YCJ- 01/placebo who achieve a 25%, 50%, 75%, or 90% reduction compared to the baseline period (from visit P0 to P1) in the number of epileptic seizures","secondaryObjectiveTranslations":[{"id":7294957,"uuid":"ab9043e8-8486-4828-b5ba-18a44c734d79","attributeTranslation":"Evaluar la proporción de sujetos en tratamiento con YCJ-01/placebo que alcanzan una reducción del 25%, 50%, 75%, o 90% con respecto al período basal (de la visita P0 a la P1) del número de crisis epilépticas.","language":7,"languageDescription":"Spanish"}]},{"id":320138,"number":3,"secondaryObjective":"To assess the proportion of patients in treatment with YCJ-01/placebo free of seizures since the initiation of the assigned treatment.","secondaryObjectiveTranslations":[{"id":7294958,"uuid":"e3b3af11-597a-42e5-a7ac-341783a295b6","attributeTranslation":"Evaluar la proporción de pacientes en tratamiento con YCJ-01/placebo libres de crisis desde el inicio del tratamiento asignado.","language":7,"languageDescription":"Spanish"}]},{"id":320139,"number":4,"secondaryObjective":"To assess the effect of YCJ-01 on control of epileptic seizures (changes in seizure severity and types) before and after the initiation of the treatment.","secondaryObjectiveTranslations":[{"id":7294959,"uuid":"38feada4-904d-4aa4-bf29-99942a005b0c","attributeTranslation":"Evaluar el efecto de YCJ-01 en el control de las crisis epilépticas (cambios en la gravedad y tipos de crisis) antes y después del inicio del tratamiento.","language":7,"languageDescription":"Spanish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":616475,"number":1,"principalInclusionCriteria":"Patients of any sex between 2 and 65 years of age (both included)","principalInclusionCriteriaTranslations":[{"id":7294945,"uuid":"611c350f-b649-4d43-bba5-25a261d0cb55","attributeTranslation":"Pacientes de cualquier sexo con edad comprendida entre 2 y 65 años (ambas incluidas).","language":7,"languageDescription":"Spanish"}]},{"id":616476,"number":2,"principalInclusionCriteria":"Diagnosis confirmed by the TSC investigator (by clinical criteria and/or genetic study).","principalInclusionCriteriaTranslations":[{"id":7294946,"uuid":"9a0cf1c4-8844-4c98-9543-c19493aa0387","attributeTranslation":"Diagnóstico confirmado por el investigador de CET (por criterios clínicos y/o estudio genético).","language":7,"languageDescription":"Spanish"}]},{"id":616477,"number":3,"principalInclusionCriteria":"Refractory epilepsy secondary to TSC, defined as that not responding successfully to traditional AEDs (2 or more), ketogenic diet, vagal nerve stimulator, and/or whose patients are not candidate for epilepsy surgery or persist with seizures after surgery.","principalInclusionCriteriaTranslations":[{"id":7294947,"uuid":"73ff3daf-7f61-4896-9313-0400f57c80dd","attributeTranslation":"Epilepsia refractaria secundaria a CET, definida como aquella que no responde exitosamente a FAEs tradicionales (2 o más), dieta cetogénica, estimulador del nervio vago, y/o no sean candidatos a cirugía de la epilepsia o persistan con crisis posteriormente a la intervención quirúrgica.","language":7,"languageDescription":"Spanish"}]},{"id":616478,"number":4,"principalInclusionCriteria":"Patients with a minimum of 4 epileptic seizures or more within 4 weeks prior to the initiation of the assigned treatment in the trial, with observable external signs (loss of consciousness or motor component).","principalInclusionCriteriaTranslations":[{"id":7294948,"uuid":"c543cd79-1cc0-4b1c-8b08-537fe09fdce7","attributeTranslation":"Pacientes con un mínimo de crisis epilépticas de 4 o más en las 4 semanas previas al inicio del tratamiento asignado en el ensayo, con signos externos observables (pérdida de conciencia o componente motor)","language":7,"languageDescription":"Spanish"}]},{"id":616479,"number":5,"principalInclusionCriteria":"Stability in AEDs doses, and in ketogenic diet/programming of the device associated with the vagal nerve stimulator with no changes for at least 4 weeks prior to the initiation of the assigned treatment.","principalInclusionCriteriaTranslations":[{"id":7294949,"uuid":"3c60a04d-309d-4a35-9bbc-9a10e7fe02dc","attributeTranslation":"Estabilidad en la dosis de FAEs y la dieta cetogénica/programación del dispositivo asociado al estimulador del nervio vago sin cambios durante al menos las 4 semanas previas al inicio del tratamiento asignado.","language":7,"languageDescription":"Spanish"}]},{"id":616480,"number":6,"principalInclusionCriteria":"Patients who are in treatment with 3 or less AEDs at the time of signing the informed consent. For the purposes of assessing eligibility, Clobazam will not be counted as AED","principalInclusionCriteriaTranslations":[{"id":7294950,"uuid":"3b6bf41b-6060-47be-b36c-c8926a91391f","attributeTranslation":"Pacientes que estén en tratamiento con 3 o menos FAEs en el momento de la firma del consentimiento informado. A efectos de valorar la elegibilidad, el Clobazam no se contabilizará como FAE.","language":7,"languageDescription":"Spanish"}]},{"id":616481,"number":7,"principalInclusionCriteria":"Willingness by patients or caregivers/family members (in case of patients who are minors or under legal guardianship) to complete the seizure diary.","principalInclusionCriteriaTranslations":[{"id":7294951,"uuid":"e8916d96-9e31-4cb1-a848-a87a81f5fced","attributeTranslation":"Disponibilidad por parte del paciente o por los cuidadores/familiares (en el caso de pacientes menores de edad o bajo tutela legal) de completar el diario de crisis epilépticas.","language":7,"languageDescription":"Spanish"}]},{"id":616482,"number":8,"principalInclusionCriteria":"In case of women of child-bearing age, for safety, those who agree to follow the required contraceptive measures from the signing of the informed consent until three months after stop the intake of the investigational medicinal product.","principalInclusionCriteriaTranslations":[{"id":7294952,"uuid":"244fd04b-5d76-4832-bb64-b45ceef879fd","attributeTranslation":"En el caso de mujeres en edad fértil, por seguridad, aquellas que se comprometan a seguir las medidas anticonceptivas requeridas desde la firma del consentimiento informado hasta tres meses después de dejar de tomar el medicamento en investigación.","language":7,"languageDescription":"Spanish"}]},{"id":616483,"number":9,"principalInclusionCriteria":"Patients who have signed the informed consent either by themselves or through a legal representative.","principalInclusionCriteriaTranslations":[{"id":7294953,"uuid":"a179ad62-edf8-43d1-b85b-55e8a4e5f345","attributeTranslation":"Pacientes que hayan firmado el consentimiento informado ya sea de forma autónoma o mediante un representante legal.","language":7,"languageDescription":"Spanish"}]}],"principalExclusionCriteria":[{"id":1059583,"number":1,"principalExclusionCriteria":"Patients who are receiving treatment on corticoids at the time of signing the informed consent.","principalExclusionCriteriaTranslations":[{"id":7294931,"uuid":"0ac9f87a-7b01-4b59-a930-beb3c6c294a5","attributeTranslation":"Pacientes que están recibiendo tratamiento con corticoides en el momento de la firma del consentimiento informado.","language":7,"languageDescription":"Spanish"}]},{"id":1059584,"number":10,"principalExclusionCriteria":"Pregnancy.","principalExclusionCriteriaTranslations":[{"id":7294932,"uuid":"7c4a7921-d480-477f-b23e-e8ed7ec0bf4b","attributeTranslation":"Embarazo.","language":7,"languageDescription":"Spanish"}]},{"id":1059585,"number":11,"principalExclusionCriteria":"Breastfeeding women","principalExclusionCriteriaTranslations":[{"id":7294933,"uuid":"70d9aeca-1fe1-41b9-ae02-866ee53643fc","attributeTranslation":"Mujeres en periodo de lactancia.","language":7,"languageDescription":"Spanish"}]},{"id":1059586,"number":12,"principalExclusionCriteria":"To have participated in another clinical trial, unless at least 5 half- lives of the investigational product have elapsed, or 12 weeks, if it is a product with cannabis oil.","principalExclusionCriteriaTranslations":[{"id":7294934,"uuid":"cb662a6e-74d7-4c69-91e5-cd98e724edb1","attributeTranslation":"Haber participado en otro ensayo clínico, salvo que hayan transcurrido al menos 5 semividas del producto en investigación o 12 semanas si es un producto con aceite de cannabis.","language":7,"languageDescription":"Spanish"}]},{"id":1059587,"number":13,"principalExclusionCriteria":"Patients who have received products with cannabis oil in the last 12 weeks.","principalExclusionCriteriaTranslations":[{"id":7294935,"uuid":"a15e6cf0-5165-42f3-a4bc-ad8100541283","attributeTranslation":"Pacientes que hayan recibido productos con aceite de cannabis en las últimas 12 semanas.","language":7,"languageDescription":"Spanish"}]},{"id":1059588,"number":2,"principalExclusionCriteria":"Patients who did not correctly follow the AED treatment in the 4 weeks prior to the intervention assigned in the trial.","principalExclusionCriteriaTranslations":[{"id":7294936,"uuid":"3bec463a-9cef-45fb-b23e-004332e260d3","attributeTranslation":"Pacientes que no se adhirieron correctamente al tratamiento los FAEs en las 4 semanas previas a la intervención asignada en el ensayo.","language":7,"languageDescription":"Spanish"}]},{"id":1059589,"number":3,"principalExclusionCriteria":"Patients who changed medication or AED dose, ketogenic diet, or the vagal stimulator during the 4 weeks prior to the initiation of the intervention assigned in the trial.","principalExclusionCriteriaTranslations":[{"id":7294937,"uuid":"75f1dcc7-cfae-4d81-8110-8690e068ab91","attributeTranslation":"Pacientes que cambiaron la medicación o dosis de los FAEs, la dieta cetogénica o el estimulador vagal, durante las 4 semanas previas al inicio de la intervención asignada en el ensayo.","language":7,"languageDescription":"Spanish"}]},{"id":1059590,"number":4,"principalExclusionCriteria":"Cardiac, renal, and hepatic failure, pancreatic insufficiency, or hematologic dysfunction with values above the normal limits of creatinine and urea; values 2 times the normal limits of transaminases, lipases, and serum amylase; platelets < 80000/mm3, and white blood cell count <3000/mm3.","principalExclusionCriteriaTranslations":[{"id":7294938,"uuid":"64c568b1-f0ec-444c-8408-cee350248c65","attributeTranslation":"Insuficiencia cardíaca, renal, hepática, pancreática, o disfunción hematológica con valores sobre los límites normales de creatinina y urea; valores 2 veces el límite normal de transaminasas, lipasa y amilasa sérica; plaquetas < 80000/mm3, y recuento de glóbulos blancos <3000/mm3.","language":7,"languageDescription":"Spanish"}]},{"id":1059591,"number":5,"principalExclusionCriteria":"Uncontrolled severe medical condition such as: hepatic disease, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic hepatitis (hepatitis B or C), uncontrolled diabetes (defined as blood glucose >150 mg%), (chronic or acute) active infections or uncontrolled severe infections, or active bleeding.","principalExclusionCriteriaTranslations":[{"id":7294939,"uuid":"358d957b-8ede-4672-a343-31664e5ef127","attributeTranslation":"Condición médica severa no controlada como: enfermedad hepática, aumento de niveles de bilirrubina superiores al doble del límite normal, cirrosis, hepatitis crónica (hepatitis B o C), diabetes no controlada (definida como glucosa sérica >150 mg%), infecciones activas (crónicas o agudas) o infecciones severas no controladas, o sangrados activos.","language":7,"languageDescription":"Spanish"}]},{"id":1059592,"number":6,"principalExclusionCriteria":"Patients or family/caregivers (in case of patients who are minors or under legal guardianship) who does not agree to comply with the requirements and trial visits or present a high risk of non-compliance with the protocol, according to the treating physician.","principalExclusionCriteriaTranslations":[{"id":7294940,"uuid":"cb49bbba-ce35-4fec-aaee-ac3e53468ab3","attributeTranslation":"Pacientes o familias/cuidadores (en el caso de pacientes menores de edad o bajo tutela legal) que no accedan a cumplir con los requerimientos y visitas del estudio, o a criterio del médico tratante presenten alto riesgo de incumplimiento del protocolo.","language":7,"languageDescription":"Spanish"}]},{"id":1059593,"number":7,"principalExclusionCriteria":"Allergy to any of the components of the investigational medicinal product/placebo.","principalExclusionCriteriaTranslations":[{"id":7294941,"uuid":"e708d9e0-f4d6-4e34-8908-74817cb44e0c","attributeTranslation":"Alergia a alguno de los componentes del medicamento en investigación/placebo.","language":7,"languageDescription":"Spanish"}]},{"id":1059594,"number":8,"principalExclusionCriteria":"Family (considering only first-degree blood relatives) or personal history of schizophrenia.","principalExclusionCriteriaTranslations":[{"id":7294942,"uuid":"27e289ed-052d-486d-9a08-ebc34c9bb0a5","attributeTranslation":"Antecedentes familiares (considerando únicamente a familiares de primer grado de consanguinidad) o personales de esquizofrenia.","language":7,"languageDescription":"Spanish"}]},{"id":1059595,"number":9,"principalExclusionCriteria":"Personal history of suicide attempts.","principalExclusionCriteriaTranslations":[{"id":7294943,"uuid":"9cde6f32-fa30-4a3d-ba3c-b857581ccaf0","attributeTranslation":"Antecedentes personales de intento de suicidio.","language":7,"languageDescription":"Spanish"}]}]},"endPoint":{"primaryEndPoints":[{"id":720191,"number":1,"endPoint":"Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the second month of treatment with respect to the baseline period; and in patient assigned to receive a placebo, changes in the number of monthly seizures in the second month of treatment with YCJ-01 with respect to the baseline period.","isPrimary":true,"endPointTranslations":[{"id":7294919,"uuid":"f2c41efb-e9f0-411e-891e-5e86232d9e4e","attributeTranslation":"Comparación en el número de crisis mensuales desde el inicio del tratamiento con YCJ-01 con el periodo basal: en\nlos pacientes asignados a recibir YCJ-01, cambio en el número de crisis mensuales en el segundo mes de tratamiento con respecto al período basal; y en los pacientes asignados a recibir placebo, cambios en el número de crisis mensuales en el segundo mes de tratamiento con YCJ-01 con respecto al periodo basal.","language":7,"languageDescription":"Spanish"}]},{"id":720192,"number":2,"endPoint":"Occurrence of Adverse Events (AE), Severe AE (SAE), AE resulting in study treatment withdrawal, AE of special interest (AESI), and changes in vital signs and laboratory values during the clinical trial. (Variable associated to the primary objective 2).","isPrimary":true,"endPointTranslations":[{"id":7294920,"uuid":"1933a5a8-fccb-4295-b61e-46afa1517cb8","attributeTranslation":"Ocurrencia de acontecimientos adversos (AA), AA graves (AAG), AA\nque resulten en la interrupción del tratamiento del estudio, AA de especial interés (AESI) y cambios en los signos vitales y los valores de laboratorio durante el ensayo clínico. (Variable asociada al objetivo primario 2).","language":7,"languageDescription":"Spanish"}]}],"secondaryEndPoints":[{"id":720193,"number":1,"endPoint":"Comparison of the number of monthly epileptic seizures between the two treatment groups and the baseline period: change in number of monthly seizures of patients assigned to receive the investigational medicinal product during the second month of treatment (from visit P2 to P3) with respect of the baseline period (from visit P0 to P1), in comparison to the second month of treatment (from visit P2 to P3) to the group receiving placebo with respect to the baseline period (from visit P0 to P1).","isPrimary":false,"endPointTranslations":[{"id":7294921,"uuid":"f9c8358e-7f77-4fee-9bef-ce75ecf0a45f","attributeTranslation":"Comparación en el número de crisis epilépticas mensuales entre los dos grupos de tratamiento y con el periodo basal: cambio en el número de crisis mensuales de los pacientes asignados a recibir el medicamento en investigación durante el segundo mes de tratamiento (de la visita P2 a la P3) con respecto al período basal (de la visita P0 a la P1) en comparación con el segundo mes de tratamiento (de la visita P2 a la P3) del grupo que recibe placebo con respecto al período basal (visita P0 a P1)","language":7,"languageDescription":"Spanish"}]},{"id":720194,"number":2,"endPoint":"Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the months of treatment after the second month of treatment with respect to the baseline period; and in patients assigned to receive placebo, changes in the number of monthly seizures in the months of treatment after the second month of treatment with YCJ-01 with respect to baseline","isPrimary":false,"endPointTranslations":[{"id":7294922,"uuid":"9da96364-9dc4-44c0-969a-374b67173990","attributeTranslation":"Comparación en el número de crisis mensuales desde el inicio del tratamiento con YCJ-01 con el periodo basa: en\nlos pacientes asignados a recibir YCJ-01, cambio en el número de crisis mensuales en los meses de tratamiento posteriores al segundo mes de tratamiento con respecto al período basal; y en los pacientes asignados a recibir placebo, cambios en el número de crisis mensuales en los meses de tratamiento posteriores al segundo mes de tratamiento con YCJ-01 con respecto al periodo basal.","language":7,"languageDescription":"Spanish"}]},{"id":720195,"number":3,"endPoint":"Comparison of the number of monthly seizures once the final dose was reached in P4-P5 with respect to the baseline period (from visit P0 to P1) in each of the patients. (Variable associated with primary objective 1).","isPrimary":false,"endPointTranslations":[{"id":7294923,"uuid":"648c3b0f-6e38-4b5f-bf32-7b1252a61b2d","attributeTranslation":"Comparación en el número de crisis mensuales una vez alcanzada la dosis final en P4-P5 con respecto al período basal (de la visita P0 a la P1) en cada uno de los pacientes. (Variable asociada al objetivo primario 1).","language":7,"languageDescription":"Spanish"}]},{"id":720196,"number":4,"endPoint":"Response rate to YCJ-01: patients who achieve a decrease of at least a 50 % of the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) in visits P3, P4, P6, and P7 will be considered responders. (Variable associated to the secondary objective 1).","isPrimary":false,"endPointTranslations":[{"id":7294924,"uuid":"b130d0b9-f3c4-415d-8f74-354fcfb9db5b","attributeTranslation":"Tasa de respuesta a YCJ-01: se considerarán respondedores a\naquellos pacientes que alcancen una reducción en el número de crisis epilépticas de al menos un 50% con respecto al período basal (de la visita P0 a la P1) en la visita P3, P4, P6 y P7. (Variable asociada al objetivo secundario 1).","language":7,"languageDescription":"Spanish"}]},{"id":720197,"number":5,"endPoint":"Response rate to YCJ-01in comparison to the placebo group: patients who achieve a decrease in at least a 50 % of the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) in visit P3 will be considered responders. (Variable associated to the secondary objective 1).","isPrimary":false,"endPointTranslations":[{"id":7294925,"uuid":"a2f3e8d5-ad7a-4d0c-b348-3aabcec3e467","attributeTranslation":"Tasa de respuesta a YCJ-01 en comparación con el grupo placebo: se considerarán respondedores a aquellos pacientes que alcancen una reducción en el número de crisis epilépticas de al menos un 50% con respecto al período basal (de la visita P0 a la P1) en la visita P3. (Variable asociada al objetivo secundario 1).","language":7,"languageDescription":"Spanish"}]},{"id":720198,"number":6,"endPoint":"Proportion of subjects in treatment with YCJ-01 achieving a 25%, 50%, 75%, 90% reduction in the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) at visits P3, P4, P6, and P7. (Variable associated to the secondary objective 2).","isPrimary":false,"endPointTranslations":[{"id":7294926,"uuid":"53eae0ae-2c82-4479-ace5-ac772395de40","attributeTranslation":"Proporción de sujetos en tratamiento con YCJ-01 que alcanzan una reducción del 25%, 50%, 75%, 90% con \nrespecto al período basal (de la visita P0 a la P1) del número de crisis epilépticas en la visita P3, P4, P6 y P7. (Variable asociada al objetivo secundario 2).","language":7,"languageDescription":"Spanish"}]},{"id":720199,"number":7,"endPoint":"Proportion of subjects in treatment with YCJ-01 compared to placebo group achieving a 25%, 50%, 75%, 90% reduction in the number of epileptic seizures with respect to the baseline period (from visit P0 to P1) at visit P3. (Variable associated to the secondary objective 2).","isPrimary":false,"endPointTranslations":[{"id":7294927,"uuid":"9b4fee5c-e99e-4483-807a-64f57f0a2521","attributeTranslation":"Proporción de sujetos en tratamiento con YCJ-01 en comparación con el grupo placebo que alcanzan una reducción del 25%, 50%, 75%, 90% con respecto al período basal (de la visita P0 a la P1) del número de crisis epilépticas en la visita P3. (Variable asociada al objetivo secundario 2).","language":7,"languageDescription":"Spanish"}]},{"id":720200,"number":8,"endPoint":"Proportion of patients in treatment with YCJ-01 free of epileptic seizures: defined as those participants with no seizure of any type from the initiation of the treatment with YCJ-01 till visit P7, or a period of time that doubles the baseline maximum interval between seizures (International League Against Epilepsy, ILAE). (Variable associated with the secondary objective 3).","isPrimary":false,"endPointTranslations":[{"id":7294928,"uuid":"d6f8be6f-89dd-4744-a8ee-7941bca7a6d6","attributeTranslation":"Proporción de pacientes en tratamiento con YCJ-01 libres de crisis\nepilépticas: definido como aquellos participantes con ninguna convulsión de ningún tipo desde el inicio del tratamiento con YCJ-01 hasta la visita P7 o un período de tiempo que duplique el intervalo máximo intercrisis basal (Liga Internacional de Epilepsia, ILAE). 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