Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 10:28 AM
Study NCT ID:
NCT06423794
Status:
TERMINATED
Last Update Posted:
2025-12-16
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BHV-7000 Open-Label Extension Bipolar Mania Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2025-12-13', 'completionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'dispFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'Up to 52 weeks', 'description': 'To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.'}, {'measure': 'Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication', 'timeFrame': 'Up to 52 weeks', 'description': 'To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).'}, {'measure': 'Number of Participants With Vital Sign Abnormalities', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation', 'timeFrame': 'Up to 52 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bipolar', 'mania', 'manic episode', 'manic state', 'bipolar disorder type 1', 'manic depressive', 'manic bipolar', 'mixed features', 'mixed episode', 'mixed mania', 'bipolar episode', 'bipolar disorder'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subjects must have successfully completed the parent study, BHV7000-204.\n2. WOCBP must have a negative urine pregnancy test at Baseline visit.\n3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.\n\nKey Exclusion Criteria:\n\n1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.\n2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.\n3. Investigator deems subject at imminent risk of danger to others or themself.'}, 'identificationModule': {'nctId': 'NCT06423794', 'briefTitle': 'BHV-7000 Open-Label Extension Bipolar Mania Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Bipolar I Disorder', 'orgStudyIdInfo': {'id': 'BHV7000-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BHV-7000', 'interventionNames': ['Drug: BHV-7000']}], 'interventions': [{'name': 'BHV-7000', 'type': 'DRUG', 'description': 'BHV-7000 75 mg taken once daily', 'armGroupLabels': ['BHV-7000']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pillar Clinical Research, LLC', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'WIRG', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'WRN', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Research Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'CIT LA', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'ProScience Research Group', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Cenexel CNS', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'country': 'United States', 'facility': 'Synergy San Diego', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'NRC Research Institute', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'CIT IE', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '90504', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Cenexel CNS', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Trials - 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