{"ctNumber":"2024-515705-26-00","ctStatus":"Authorised","startDateEU":"2024-11-11","decisionDate":"2024-10-15T21:27:52.903","publishDate":"2025-12-12T02:32:08.360472834","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":109052,"rowSubjectCount":0,"products":[{"id":452046,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11564776","productPharmForm":"LYOPHILISATE FOR SUSPENSION FOR INJECTION","euMpNumber":"PRD11564776","prodAuthStatus":1,"prodName":"Acyl-ghreline","pharmForm":"LYOPHILISATE FOR SUSPENSION FOR INJECTION","sponsorProductCode":"G-3370-R","activeSubstanceName":"LENOMORELIN","euSubstNumber":"SUB189223","nameOrg":"STICHTING RIJNSTATE ZIEKENHUIS","productSubstances":[{"productPk":"11564776","substancePk":"352552","nameOrg":"STICHTING RIJNSTATE ZIEKENHUIS","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LENOMORELIN","substanceEvCode":"SUB189223","synonyms":["GHRELIN","ACYL-GHRELIN","SUN11031"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"µg microgram(s)","maxDailyDoseAmount":"1200","doseUomTotal":"µg microgram(s)","maxTotalDoseAmount":"6000","maxTreatmentPeriod":5,"timeUnitCode":"1","otherMedicinalProduct":"Hormone","evCode":"PRD11564776","sponsorProductCodeEdit":"G-3370-R","devices":[],"characteristics":["11"],"routes":["INTRAVENOUS BOLUS INJECTION/IV INFUSION"],"allSubstancesChemicals":false,"productName":"Acyl-ghreline","jsonActiveSubstanceNames":"lenomorelin","pharmaceuticalFormDisplay":"LYOPHILISATE FOR SUSPENSION FOR INJECTION"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"Multicentre Randomized trial of Ghrelin in anterior circulation ischemic stroke treated with endovascular thrombectomy. A randomized phase 2 trial.","fullTitleTranslations":[{"id":8807585,"uuid":"ebd3f665-ecff-4fb8-b130-739b308d44ea","attributeTranslation":"Multicenter gerandomiseerde trial naar het effect van behandeling met ghreline op herstel van patiënten met een herseninfarct. Een gerandomiseerde fase 2 trial.","language":37,"languageDescription":"Dutch (Netherlands)"}],"publicTitle":"Multicentre Randomized trial of Ghrelin in anterior circulation ischemic stroke treated with endovascular thrombectomy. A randomized phase 2 trial.","publicTitleTranslations":[{"id":8807593,"uuid":"ca7e4e22-9498-48ac-8033-fab0ebf1dee2","attributeTranslation":"Multicenter gerandomiseerde trial naar het effect van behandeling met ghreline op herstel van patiënten met een herseninfarct. Een gerandomiseerde fase 2 trial.","language":37,"languageDescription":"Dutch (Netherlands)"}],"secondaryIdentifyingNumbers":{"nctNumber":{"id":462554,"number":"NCT05726240"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"In this project, acyl ghrelin will be tested in a phase 2 randomized controlled trial to estimate the  effect on the severity of the neurological deficit at seven days after symptom onset in patients with  acute ischemic stroke, who are treated with EVT. Intravenous treatment with acylated ghrelin  600micrg twice daily for five days will be compared with standard care.","trialCategoryId":99406},"medicalCondition":{"partIMedicalConditions":[{"id":112989,"medicalCondition":"Stroke","medicalConditionTranslations":[{"id":8807570,"uuid":"305df4e3-247f-444d-b649-c452c8939064","attributeTranslation":"Herseninfarct","language":37,"languageDescription":"Dutch (Netherlands)"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000065477,"version":"22.1","level":"LLT","termName":"Ischemic stroke","classificationCode":"10055221","organClass":10029205,"active":false}]},"trialObjective":{"trialScopes":[{"code":"5","trialScopeId":328824}],"mainObjective":"The primary objective of this study is to assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke \ncaused by large vessel occlusion of the anterior circulation and treated with EVT.","mainObjectiveTranslations":[],"secondaryObjectives":[{"id":379018,"number":1,"secondaryObjective":"Effects of ghrelin on functional outcome at 90 days","secondaryObjectiveTranslations":[{"id":8807594,"uuid":"9e5e2486-3d04-444c-95fe-4741c5d9ce35","attributeTranslation":"Effects van ghreline op functionele uitkomsten op 90 dagen","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379019,"number":2,"secondaryObjective":"Effects of ghrelin on neurological deficit at one and three days after symptom onset","secondaryObjectiveTranslations":[{"id":8807595,"uuid":"1450bd53-529f-48d1-84ef-557a4e1c7349","attributeTranslation":"Effecten van ghreline op neurologische uitval op 1 en 3 dagen na het herseninfarct","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379020,"number":3,"secondaryObjective":"Effects of ghrelin on infarct size at day 3 +/- 1","secondaryObjectiveTranslations":[{"id":8807596,"uuid":"77c83aea-6deb-4646-be81-8fd1506d0e3b","attributeTranslation":"Effecten van ghreline op grootte van het infarct op dag 3","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379021,"number":4,"secondaryObjective":"Effects of ghrelin on blood glucose levels at day 1-7","secondaryObjectiveTranslations":[{"id":8807597,"uuid":"5a117a0d-d4d4-4d56-9495-04d4243da6ad","attributeTranslation":"Effecten van ghreline op bloed glucose waarden op dag 1-7","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379022,"number":5,"secondaryObjective":"Effects of ghrelin on blood pressure at day 1-7","secondaryObjectiveTranslations":[{"id":8807598,"uuid":"4f56c81f-1861-48ef-8f39-49586d297f9f","attributeTranslation":"Effecten van ghreline op gemiddelde bloeddruk op dag 1-7","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379023,"number":6,"secondaryObjective":"Effects of ghrelin on temperature at day 1-7","secondaryObjectiveTranslations":[{"id":8807599,"uuid":"2bf87be9-b2f5-401d-945e-f0aab339ef46","attributeTranslation":"Effecten van ghreline op temperatuur op dag 1-7","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379024,"number":7,"secondaryObjective":"Effects of ghrelin on safety (numer of SAEs; mortality)","secondaryObjectiveTranslations":[{"id":8807600,"uuid":"c37295c1-cea4-4f94-9695-ba84c4ed415e","attributeTranslation":"Effecten van ghreline op veiligheid (aantal SAE's, overlijdens)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":379025,"number":8,"secondaryObjective":"Effects of ghrelin on cognitive functioning at 90 days (expressed as the score on the telephone version of the Montreal Cognitive Assessment (t-MoCA)","secondaryObjectiveTranslations":[{"id":8807601,"uuid":"e31ba216-6a96-4f20-88d0-a25e525c264a","attributeTranslation":"Effecten van ghreline op het cognitief functioneren op 90 dagen (uitgedrukt als de score op de telefonische versie van de Montreal Cognitive Assessment (t-MoCA))","language":37,"languageDescription":"Dutch (Netherlands)"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":727745,"number":1,"principalInclusionCriteria":"a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the  anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery)  confirmed by neuro-imaging (CTA or MRA)","principalInclusionCriteriaTranslations":[{"id":8807586,"uuid":"f6cf630a-f3ef-4489-9b0a-f075eadddc0b","attributeTranslation":"Een klinische diagnose van een herseninfarct, veroorzaakt door veroorzaakt door afsluiting van een grote slagader in de voorste bloedsomloop van de hersenen (distale intracraniële halsslagader of middelste (M1/proximale M2) hersenslagader), bevestigd door beeldvorming van de hersenen (CTA of MRA).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":727746,"number":2,"principalInclusionCriteria":"treatment with EVT, defined as groin puncture in the angio suite","principalInclusionCriteriaTranslations":[{"id":8807587,"uuid":"738048fb-652c-4058-a824-66258a67e4d6","attributeTranslation":"Behandeling met endovasculaire trombectomie, gedefinieerd als liespunctie in de angiosuite","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":727747,"number":3,"principalInclusionCriteria":"CT or MRI ruling out intracranial hemorrhage","principalInclusionCriteriaTranslations":[{"id":8807588,"uuid":"4c7de93d-baea-480b-8121-fae54f56fdb8","attributeTranslation":"Intracraniële bloeding uitgesloten met CT of MRI","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":727748,"number":4,"principalInclusionCriteria":"a pre-EVT score of at least 10 on the NIHSS","principalInclusionCriteriaTranslations":[{"id":8807589,"uuid":"140b8a44-06d4-44c8-884b-3b590497266e","attributeTranslation":"Een score van minimaal 10 op de NIHSS voorafgaand aan de endovasculaire trombectomie","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":727749,"number":5,"principalInclusionCriteria":"age of 18 years or older","principalInclusionCriteriaTranslations":[{"id":8807590,"uuid":"0f2e7523-3828-4f32-9550-976872875edb","attributeTranslation":"Leeftijd van 18 jaar of ouder","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":727750,"number":6,"principalInclusionCriteria":"written informed consent (deferred)","principalInclusionCriteriaTranslations":[{"id":8807591,"uuid":"dec4c873-96ee-47f0-82a2-719d5afa5cb6","attributeTranslation":"(uitgestelde) schriftelijke geïnformeerde toestemming","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":727751,"number":7,"principalInclusionCriteria":"possibility to start trial treatment within 6 hours of stroke onset","principalInclusionCriteriaTranslations":[{"id":8807592,"uuid":"90c9b30a-6095-4f3d-8f07-6a645e04ec3f","attributeTranslation":"Mogelijkheid om binnen 6 uur na het herseninfarct te starten met de studiebehandeling.","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"principalExclusionCriteria":[{"id":1248451,"number":1,"principalExclusionCriteria":"pre-stroke disability defined as mRS ≥ 2","principalExclusionCriteriaTranslations":[{"id":8807582,"uuid":"65c2b6df-6625-412d-9c86-82abb3a1ac43","attributeTranslation":"Invaliditeit voorafgaand aan het herseninfarct, gedefinieerd als mRS ≥ 2","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1248452,"number":2,"principalExclusionCriteria":"life expectancy shorter than one year","principalExclusionCriteriaTranslations":[{"id":8807583,"uuid":"39a74011-bbe8-43f3-8c2b-3b8bc4d4621d","attributeTranslation":"Levensverwachting korter dan een jaar","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1248453,"number":3,"principalExclusionCriteria":"child-bearing potential","principalExclusionCriteriaTranslations":[{"id":8807584,"uuid":"6c86979b-a598-4b3e-bd31-3a850984582c","attributeTranslation":"Vruchtbare potentie","language":37,"languageDescription":"Dutch (Netherlands)"}]}]},"endPoint":{"primaryEndPoints":[{"id":851576,"number":1,"endPoint":"score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier","isPrimary":true,"endPointTranslations":[{"id":8807571,"uuid":"906ec645-79d6-48c8-bb09-1a569fa6de13","attributeTranslation":"Score op de NIHSS zeven dagen (±1) na het ontstaan van het herseninfarct (of bij ontslag naar huis, indien eerder).","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"secondaryEndPoints":[{"id":851577,"number":1,"endPoint":"the score on the mRS at 90 days (±14) after stroke onset","isPrimary":false,"endPointTranslations":[{"id":8807572,"uuid":"94fc4f42-62a5-430d-b742-265d90df913b","attributeTranslation":"Score op de mRS op 90 dagen (±14) na het ontstaan van het herseninfarct","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851578,"number":2,"endPoint":"the score on Barthel index at 90 days (±14) after stroke onset","isPrimary":false,"endPointTranslations":[{"id":8807573,"uuid":"0edf8926-7e21-48cf-9a38-ea487756eeac","attributeTranslation":"Score op de Barthel Index op 90 dagen (±14) na het ontstaan van het herseninfarct","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851579,"number":3,"endPoint":"mortality at 90 days (±14)","isPrimary":false,"endPointTranslations":[{"id":8807574,"uuid":"d53088ea-5c18-44e4-b82d-2db3df21423b","attributeTranslation":"Overlijden op 90 dagen (±14)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851580,"number":4,"endPoint":"scores on the NIHSS at 24 (±6) and 72 (±12) hours after stroke onset","isPrimary":false,"endPointTranslations":[{"id":8807575,"uuid":"4eba917d-1e0b-4da6-9ca6-9ee7f8e2643e","attributeTranslation":"Score op de NIHSS op 24 (±6) en 72 (±12) uur na het ontstaan van het herseninfarct","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851581,"number":5,"endPoint":"score on the telephone version of the Montreal Cognitive Assessment (t-MoCA) at 90 days  (±14)","isPrimary":false,"endPointTranslations":[{"id":8807576,"uuid":"a93162e0-af92-46fd-9dad-cbb56fbf9300","attributeTranslation":"Score op de telefonische versie van de Montreal Cognitive Assessment (t-MoCA) op 90 dagen (±14) na het ontstaan van het herseninfarct","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851582,"number":6,"endPoint":"infarct size at 72 hours (±24) (based on MRI measurements)","isPrimary":false,"endPointTranslations":[{"id":8807577,"uuid":"2550ad28-1d1c-4952-875f-240fce2c97f1","attributeTranslation":"infarctgrootte op 72 uur (±24) (gebaseerd op MRI-metingen)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851583,"number":7,"endPoint":"blood glucose levels at days 1-7 (or until discharge)","isPrimary":false,"endPointTranslations":[{"id":8807578,"uuid":"68cc207d-cefc-41f8-9adc-ced682a1b802","attributeTranslation":"bloedglucosewaarden op dag 1-7 (of tot ontslag)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851584,"number":8,"endPoint":"blood pressure at days 1-7 (or until discharge)","isPrimary":false,"endPointTranslations":[{"id":8807579,"uuid":"62b31647-32c3-4e93-b5f7-6e20129b6453","attributeTranslation":"bloeddruk op dag 1-7 (of tot ontslag)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851585,"number":9,"endPoint":"body temperature at days 1-7 (or until discharge)","isPrimary":false,"endPointTranslations":[{"id":8807580,"uuid":"b1d5e7f0-54d4-4072-9cf3-576beadb6a2a","attributeTranslation":"lichaamstemperatuur op dag 1-7 (of tot ontslag)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":851586,"number":10,"endPoint":"SAEs","isPrimary":false,"endPointTranslations":[{"id":8807581,"uuid":"b73e0635-a4e1-470f-af26-ee48d9e76dfe","attributeTranslation":"Ernstige bijwerkingen","language":37,"languageDescription":"Dutch (Netherlands)"}]}]},"trialDuration":{"estimatedEndDate":"2026-04-30","estimatedRecruitmentStartDate":"2024-10-01"},"sourceOfMonetarySupport":[{"id":79260,"organisationName":"Dutch Heart Foundation"},{"id":79259,"organisationName":"Rijnstate Vriendenfonds"}],"populationOfTrialSubjects":{"ageRanges":[{"id":299329,"ageRangeCategoryCode":"4","ageRangeCategory":"4"},{"id":299328,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":true},"individualParticipantData":{"planToShareIPD":"3"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-11","conclusionDate":"2025-12-11","therapeuticAreas":[{"code":"10","name":"Diseases [C] - Nervous System Diseases [C10]"},{"code":"14","name":"Diseases [C] - Cardiovascular Diseases [C14]"}],"medicalConditions":[{"id":112989,"medicalCondition":"Stroke","isConditionRareDisease":false}],"sponsors":[{"id":122699,"primary":true,"publicContacts":[{"id":362040,"type":"Public","functionalName":"Prof. dr. J. Hofmeijer","functionalEmailAddress":"ResearchNeurologie@rijnstate.nl","telephone":"0880058888","organisation":{"id":530751,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Rijnstate Ziekenhuis Stichting","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021667","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":362041,"type":"Scientific","functionalName":"Prof. dr. J. Hofmeijer","functionalEmailAddress":"jhofmeijer@rijnstate.nl","telephone":"0880058877","organisation":{"id":530751,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Rijnstate Ziekenhuis Stichting","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021667","organisationLocationStatus":"Active"}}],"thirdParties":[],"organisation":{"id":530751,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Rijnstate Ziekenhuis Stichting","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021667","organisationLocationStatus":"Active"},"addresses":[{"id":498300,"organisation":{"id":530751,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Rijnstate Ziekenhuis Stichting","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021667","organisationLocationStatus":"Active"},"address":{"addressId":534826,"oneLine":"Wagnerlaan 55","addressLine1":"Wagnerlaan 55","addressLine2":"","addressLine3":"","addressLine4":"","city":"Arnhem","postcode":"6815 AD","country":2029,"countryName":"Netherlands"},"isBusinessKeyValidated":true,"businessKey":"ORG-100021667"}],"isCommercial":false,"commercial":"Non-Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"In this project, acyl ghrelin will be tested in a phase 2 randomized controlled trial to estimate the  effect on the severity of the neurological deficit at seven days after symptom onset in patients with  acute ischemic stroke, who are treated with EVT. Intravenous treatment with acylated ghrelin  600micrg twice daily for five days will be compared with standard care.","partOneTherapeuticAreas":[{"id":1021759,"therapeuticArea":{"code":"10","name":"Diseases [C] - Nervous System Diseases [C10]"}},{"id":1021758,"therapeuticArea":{"code":"14","name":"Diseases [C] - Cardiovascular Diseases [C14]"}}],"productRoleGroupInfos":[{"id":338921,"comments":"Acyl-ghreline","productRoleCode":"1","productRoleName":"Test","products":[{"id":452046,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11564776","productPharmForm":"LYOPHILISATE FOR SUSPENSION FOR INJECTION","euMpNumber":"PRD11564776","prodAuthStatus":1,"prodName":"Acyl-ghreline","pharmForm":"LYOPHILISATE FOR SUSPENSION FOR INJECTION","sponsorProductCode":"G-3370-R","activeSubstanceName":"LENOMORELIN","euSubstNumber":"SUB189223","nameOrg":"STICHTING RIJNSTATE ZIEKENHUIS","productSubstances":[{"productPk":"11564776","substancePk":"352552","nameOrg":"STICHTING RIJNSTATE ZIEKENHUIS","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LENOMORELIN","substanceEvCode":"SUB189223","synonyms":["GHRELIN","ACYL-GHRELIN","SUN11031"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"µg microgram(s)","maxDailyDoseAmount":"1200","doseUomTotal":"µg microgram(s)","maxTotalDoseAmount":"6000","maxTreatmentPeriod":5,"timeUnitCode":"1","otherMedicinalProduct":"Hormone","evCode":"PRD11564776","sponsorProductCodeEdit":"G-3370-R","devices":[],"characteristics":["11"],"routes":["INTRAVENOUS BOLUS INJECTION/IV INFUSION"],"allSubstancesChemicals":false,"productName":"Acyl-ghreline","jsonActiveSubstanceNames":"lenomorelin","pharmaceuticalFormDisplay":"LYOPHILISATE FOR SUSPENSION FOR INJECTION"}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":142778,"mscId":33999,"mscInfo":{"id":33999,"clinicalTrialId":16650,"countryOrganisationId":2029,"reportingStatusCode":"Authorised","fromDate":"2024-10-01","toDate":"2024-10-01","isProposedRms":true,"countryName":"Netherlands","organisationInfo":{},"firstDecisionDate":"2024-10-15","trialStatus":"Authorised","trialPeriod":[{"id":44515,"trialStartDate":"2024-11-11","fromDate":"2024-12-02"},{"id":44516,"trialStartDate":"2024-11-11","fromDate":"2024-12-02"},{"id":44517,"trialStartDate":"2024-11-11","fromDate":"2024-12-02"}],"trialRecruitmentPeriod":[{"id":58822,"recruitmentStartDate":"2024-11-22","fromDate":"2024-12-02"},{"id":58823,"recruitmentStartDate":"2024-11-22","fromDate":"2024-12-02"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":60749,"trialStartDate":"2024-11-11","fromDate":"2024-12-02"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-11-22"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":52722,"mscId":33999,"trialStatus":"Under evaluation","trialStatusDate":"2024-09-17T11:19:34.074"},{"id":57374,"mscId":33999,"trialStatus":"Authorised","trialStatusDate":"2024-10-15T21:27:52.759"}],"applicationTypeMsc":"1","mscName":"Netherlands","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-10-15","decision":"authorized_conditions","decisionDate":"2024-10-15"},"decisionDate":"2024-10-15","recruitmentSubjectCount":80,"trialSites":[{"id":930430,"organisationAddressInfo":{"id":509225,"organisation":{"id":541724,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Medisch Spectrum Twente","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043548","organisationLocationStatus":"Active"},"address":{"addressId":546905,"oneLine":"Koningsplein 1","addressLine1":"Koningsplein 1","addressLine2":"","addressLine3":"","addressLine4":"","city":"Enschede","postcode":"7512 KZ","country":2029,"countryName":"Netherlands"},"phone":"0031534872850","email":"Renate.Arntz@mst.nl","isBusinessKeyValidated":true,"businessKey":"ORG-100043548"},"personInfo":{"id":1038415,"firstName":"R.M.","lastName":"Arntz","telephone":"0031534872850","email":"Renate.Arntz@mst.nl","title":"1"},"departmentName":"Neurology"},{"id":930432,"organisationAddressInfo":{"id":509213,"organisation":{"id":541712,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Isala Klinieken Stichting","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021668","organisationLocationStatus":"Active"},"address":{"addressId":546892,"oneLine":"Dokter Van Heesweg 2","addressLine1":"Dokter Van Heesweg 2","addressLine2":"","addressLine3":"","addressLine4":"","city":"Zwolle","postcode":"8025 AB","country":2029,"countryName":"Netherlands"},"phone":"0031886242458","email":"c.j.b.a.kersten@isala.nl","isBusinessKeyValidated":true,"businessKey":"ORG-100021668"},"personInfo":{"id":1038417,"firstName":"C.J.A.B","lastName":"Kersten","telephone":"0031886242458","email":"c.j.b.a.kersten@isala.nl","title":"1"},"departmentName":"Neurology"},{"id":930431,"organisationAddressInfo":{"id":509209,"organisation":{"id":541708,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Universitair Medisch Centrum Utrecht","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100008351","organisationLocationStatus":"Active"},"address":{"addressId":546887,"oneLine":"Heidelberglaan 100","addressLine1":"Heidelberglaan 100","addressLine2":"","addressLine3":"","addressLine4":"","city":"Utrecht","postcode":"3584 CX","country":2029,"countryName":"Netherlands"},"phone":"0031887571833","email":"h.b.vanderworp@umcutrecht.nl","isBusinessKeyValidated":true,"businessKey":"ORG-100008351"},"personInfo":{"id":1038416,"firstName":"H.B.","lastName":"van der Worp","telephone":"0031887571833","email":"h.b.vanderworp@umcutrecht.nl","title":"2"},"departmentName":"Neurology"},{"id":930429,"organisationAddressInfo":{"id":498810,"organisation":{"id":531262,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Rijnstate Ziekenhuis Stichting","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021667","organisationLocationStatus":"Active"},"address":{"addressId":535423,"oneLine":"Wagnerlaan 55","addressLine1":"Wagnerlaan 55","addressLine2":"","addressLine3":"","addressLine4":"","city":"Arnhem","postcode":"6815 AD","country":2029,"countryName":"Netherlands"},"phone":"0031880058888","email":"jhofmeijer@rijnstate.nl","isBusinessKeyValidated":true,"businessKey":"ORG-100021667"},"personInfo":{"id":1038414,"firstName":"Jeannette","lastName":"Hofmeijer","telephone":"0031880058888","email":"jhofmeijer@rijnstate.nl","title":"2"},"departmentName":"Neurology"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":29139,"type":"INITIAL","status":"Authorised","ctNumber":"2024-515705-26-00","trialStatus":"Authorised","submissionDate":"2024-09-17","partI":{"assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2024-10-15"},"partIIInfo":[{"id":142778,"mscId":33999,"mscInfo":{"id":33999,"mscName":"Netherlands","countryOrganisationId":2029,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-10-15","decision":"authorized_conditions","decisionDate":"2024-10-15","reportingStatusCode":"Authorised","countryName":"Netherlands","trialStatus":"Authorised","firstDecisionDate":"2024-10-15"},"applicationStatusCode":"Authorised"}],"decisionDate":"2024-10-15","ctMSCsByApplication":[{"id":33999,"mscName":"Netherlands","reportingStatusCode":"Authorised"}],"businessKey":"IN","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":42141,"applicationId":29139,"mscId":33999,"mscName":"Netherlands","decisionDate":"2024-10-15T21:27:52.903","decision":"authorized_conditions","assessmentOutcome":"acceptable","eventType":"decision","part2Id":142778,"part1Id":56881,"applicationType":"INITIAL","isRMS":true}]},{"id":65723,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2024-515705-26-00","trialStatus":"Authorised","submissionDate":"2025-09-23","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-11"},"partIIInfo":[],"decisionDate":"2025-12-11","ctMSCsByApplication":[{"id":33999,"mscName":"Netherlands","reportingStatusCode":"Authorised"}],"businessKey":"SM-1","modScope":"PART_I","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":101961,"applicationId":65723,"mscId":33999,"mscName":"Netherlands","decisionDate":"2025-12-11T16:01:36.045","decision":"authorized","eventType":"decision","part1Id":109052,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Netherlands","mscId":33999,"firstDecisionDate":"2024-10-15T21:27:52.903","lastDecisionDate":"2024-10-15T21:27:52.903","mscPublicStatusCode":4}],"eudraCt":{"isTransitioned":true,"eudraCtCode":"2022-001632-28"}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":33999,"mscName":"Netherlands","events":[{"notificationType":"START_OF_TRIAL","date":"2024-11-11"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-11-22"}]}],"unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{},"documents":[{"title":"K1_Recruitment arrangements","uuid":"e1092928-849d-47bf-b393-cddcf7b5a705","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1","systemVersion":"1"},{"title":"L1_SIS and ICF patient deferred consent version_not for publ_RFI-CT-2024-515705-26-00-IN-001-02","uuid":"0cf65440-1d82-47d8-9f09-bca4c3fb8692","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient deferred consent version_not for publ_RFI-CT-2024-515705-26-00-IN-001-02_TC","uuid":"1f94831e-dbc9-4383-98ec-0b0f9a81c6dd","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient 2nd instance_for publication","uuid":"fa738d7a-afd8-4e77-82f5-10dcfe9a6197","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.2","systemVersion":"1"},{"title":"L1_SIS and ICF patient deferred consent_not for publication","uuid":"52fd694b-3caf-4511-9740-d352d13810b4","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient deferred consent_for publication","uuid":"c0241122-1e22-481f-a4d5-a3a83590bc1f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF legal representative_for publication","uuid":"47e7a84f-edde-4c1e-9f06-42982745ebcc","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF legal representative_not for publication","uuid":"add62d63-a9a3-4617-a35e-88c899cb0a83","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient deferred consent_for publication_RFI-CT-2024-515705-26-00-IN-001-02","uuid":"15bc7e63-2e4a-4ee8-b25a-004ed62ad452","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient 2nd instance_not for publication_RFI-CT-2024-515705-26-00-IN-001-02","uuid":"d15c35d3-1610-4660-a4d0-75d82cba39f1","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.2","systemVersion":"1"},{"title":"L1_SIS and ICF patient 2nd instance_not for publication","uuid":"d4c8f666-b202-417f-a8df-8b392ae12d71","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.2","systemVersion":"1"},{"title":"L1_SIS and ICF legal representative_for publication_RFI-CT-2024-515705-26-00-IN-001-02","uuid":"68cd7adf-5188-432e-b6af-d7d512054743","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF legal representative_not for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC","uuid":"606bf23c-72b0-467e-8b1b-26aa1388ba7f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF legal representative_not for publication_RFI-CT-2024-515705-26-00-IN-001-02","uuid":"0e652c46-5264-486d-a9a3-c5abfbb31f7a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient deferred consent_for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC","uuid":"35f81d97-01ef-42d2-b042-9584d9f67327","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient 2nd instance_for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC","uuid":"8e550019-3f9f-4b5c-96f8-dc47c5c6ba66","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.2","systemVersion":"1"},{"title":"L1_SIS and ICF patient 2nd instance_not for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC","uuid":"3e7bc90f-a4c8-4204-bc37-bf392b7cdf49","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.2","systemVersion":"1"},{"title":"L1_SIS and ICF legal representative_for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC","uuid":"102f420c-1b1c-45e3-90b2-2485960b8ef8","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.3","systemVersion":"1"},{"title":"L1_SIS and ICF patient 2nd instance_for publication_RFI-CT-2024-515705-26-00-IN-001-02","uuid":"6eeeb9c2-aaeb-4c5a-9d5f-11ac8739379d","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","fileType":"PDF","associatedEntityId":142778,"manualVersion":"1.2","systemVersion":"1"},{"title":"D1 protocol 2024-515705-26-00","uuid":"b4f4eb50-3f5f-4b79-8172-257a95ee0d52","documentType":"104","documentTypeLabel":"Protocol (for publication)","fileType":"PDF","associatedEntityId":109052,"manualVersion":"1.4","systemVersion":"3"},{"title":"D1_Protocol_synopsis_Dutch 2024-515705-26-00","uuid":"8c3538b8-5c69-4530-9558-1cc9af1c5760","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","fileType":"PDF","associatedEntityId":109052,"manualVersion":"1","systemVersion":"1"}],"trialRegion":"EEA","trialRegionCode":1,"correctiveMeasures":[]}