Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-21 @ 7:52 PM
Study NCT ID:
NCT02928393
Status:
TERMINATED
Last Update Posted:
2019-01-02
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020244', 'term': 'Infarction, Middle Cerebral Artery'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720034', 'term': 'basmisanil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Low participant enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-28', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in FMMS Score at Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Baseline (Day 1) up to 28 days after last dose of study drug (latest at Day 118)'}, {'measure': 'Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Day 30', 'timeFrame': 'Baseline (Day 1), Day 30'}, {'measure': 'Change From Baseline in MoCA Score at Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score At Day 3', 'timeFrame': 'Baseline (Day 1), Day 3'}, {'measure': 'Change From Baseline in NIHSS Score At Day 10', 'timeFrame': 'Baseline (Day 1), Day 10'}, {'measure': 'Change From Baseline in NIHSS Score At Day 30', 'timeFrame': 'Baseline (Day 1), Day 30'}, {'measure': 'Change From Baseline in NIHSS Score At Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'Change From Baseline in NIHSS Score At 28 Days After Last Dose', 'timeFrame': 'Baseline (Day 1) and at 28 days after last dose of study drug (latest on Day 118)'}, {'measure': 'Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score At Day 3', 'timeFrame': 'Baseline (Day 1), Day 3'}, {'measure': 'Change From Baseline in C-SSRS Score At Day 30', 'timeFrame': 'Baseline (Day 1), Day 30'}, {'measure': 'Change From Baseline in C-SSRS Score At Day 60', 'timeFrame': 'Baseline (Day 1), Day 60'}, {'measure': 'Change From Baseline in C-SSRS Score At Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'Change From Baseline in C-SSRS Score At 28 Days After Last Dose', 'timeFrame': 'Baseline (Day 1), at 28 days after last dose of study drug (latest on Day 118)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Modified Rankin Scale (mRS) Score At Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'mRS Score At Day 90', 'timeFrame': 'Day 90'}, {'measure': 'Change From Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'Change From Baseline in FMA Subscale Score at Day 90', 'timeFrame': 'Baseline (Day 1), Day 90'}, {'measure': 'Apparent Oral Clearance (CL/F) of Basmisanil', 'timeFrame': 'Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Basmisanil', 'timeFrame': 'Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3'}, {'measure': 'Apparent Volume of Distribution at Steady States (Vss) of Basmisanil', 'timeFrame': 'Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3'}, {'measure': 'Area Under the Curve [AUC] of Basmisanil', 'timeFrame': 'Predose (Hour 0) (prior to morning dose) on Days 3, 10, 30, 90; 4 and 8 hours post-morning dose on Day 1; and 4 hours post-morning dose on Day 3'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Motor impairment', 'Stroke recovery', 'Middle cerebral artery stroke', 'Fugl Meyer', 'Fugl-Meyer Motor Scale (FMMS)'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiologic assessment confirming an acute middle cerebral artery ischemic stroke\n* Index stroke occurred within the past 3-4 days\n* Inpatient males and females\n* Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to (\\</=) 35\n* Sufficient speech, vision and hearing to participate in study evaluations\n\nExclusion Criteria:\n\n* NIHSS greater than (\\>) 20\n* Severe aphasia that prevents a participant from following directions in rehabilitation\n* Significant deficit from prior strokes or pre-existing motor deficit\n* History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months\n* Known or suspected clinical seizure post-index stroke\n* History of pre-existing dementia or use of medications for dementia\n* History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke\n* Due to undergo carotid surgery within the next 4 months\n* Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer)\n* Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments\n* Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult'}, 'identificationModule': {'nctId': 'NCT02928393', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults With Severe Motor Impairment Following an Ischemic Stroke', 'orgStudyIdInfo': {'id': 'BP29937'}, 'secondaryIdInfos': [{'id': '2015-003227-66', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basmisanil', 'description': 'Basmisanil at a dose of 240 milligrams (mg) orally twice daily for 90 days.', 'interventionNames': ['Drug: Basmisanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to basmisanil orally twice daily for 90 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Basmisanil', 'type': 'DRUG', 'otherNames': ['RO5186582'], 'description': 'Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.', 'armGroupLabels': ['Basmisanil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besancon Hopital Jean Minjoz; Service de Neurologie', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin Tripode - CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Hopital la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Hôpital General - Service de neurologie; Service de neurologie', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clnico Universitario de Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}