Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 4:45 AM
Study NCT ID:
NCT04708834
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-17
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Sponsor:
Organization:
Raw JSON
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'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment', 'timeFrame': 'Change from Baseline to week 240', 'description': "Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obsessive compulsive disorder', 'OCD', 'troriluzole', 'Biohaven'], 'conditions': ['Obsessive Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.\n* Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.\n* It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study\n\nKey Exclusion Criteria:\n\n* Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.\n* Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.\n* Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;'}, 'identificationModule': {'nctId': 'NCT04708834', 'briefTitle': 'Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder', 'orgStudyIdInfo': {'id': 'BHV4157-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Troriluzole (BHV-4157)', 'description': '200 mg daily first 2 weeks, 280 daily following first 2 weeks', 'interventionNames': ['Drug: Troriluzole (BHV-4157)']}], 'interventions': [{'name': 'Troriluzole (BHV-4157)', 'type': 'DRUG', 'description': '200 mg daily first 2 weeks, 280 daily following first 2 weeks', 'armGroupLabels': ['Troriluzole (BHV-4157)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85226', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Metropolitan Neuro Behavioral Institute', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alea Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'NoeisisPharma, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72209', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Atria Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 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