Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-02 @ 12:14 PM
Study NCT ID:
NCT06425159
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'C562694', 'term': 'Epilepsy, Idiopathic Generalized'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}, {'id': 'D020190', 'term': 'Myoclonic Epilepsy, Juvenile'}, {'id': 'D004832', 'term': 'Epilepsy, Absence'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period', 'timeFrame': 'Baseline to Week 24 of Double-Blind Treatment Period', 'description': 'To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with freedom of GTC seizures during DBT Phase', 'timeFrame': 'Baseline to Week 24 of Double-Blind Treatment Period', 'description': 'To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.'}, {'measure': 'Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs', 'timeFrame': 'Baseline to Week 24 of Double-Blind Treatment Period', 'description': 'To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'Baseline to Week 24 of Double-Blind Treatment Period', 'description': 'To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Generalized Epilepsy', 'Generalized', 'Epilepsy', 'tonic-clonic', 'generalized tonic-clonic', 'tonic', 'clonic', 'seizure', 'refractory epilepsy', 'generalized tonic-clonic alone', 'juvenile myoclonic epilepsy', 'juvenile absence epilepsy'], 'conditions': ['Generalized Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and Female participants 18 to 75 years of age at time of consent.\n* Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.\n\n 1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks\n 2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).\n* Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.\n* Ability of subject or caregiver to keep accurate seizure diaries\n* Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).\n* Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.\n\nExclusion Criteria:\n\n* History of status epilepticus (convulsive status epilepticus for \\> 5 minutes or focal status epilepticus with impaired conscious for \\> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.\n* History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.\n* Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator"}, 'identificationModule': {'nctId': 'NCT06425159', 'acronym': 'SHINE', 'briefTitle': 'A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension', 'orgStudyIdInfo': {'id': 'BHV7000-304'}, 'secondaryIdInfos': [{'id': '2023-508812-45-00', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BHV-7000 75 mg', 'interventionNames': ['Drug: BHV-7000']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BHV-7000', 'type': 'DRUG', 'description': 'BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily', 'armGroupLabels': ['BHV-7000 75 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo taken once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kamesha Mangadi', 'role': 'CONTACT', 'email': 'kamesha.mangadi@accelclinical.com', 'phone': '205-757-8212'}], 'facility': 'Accel Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caitlin Goodman', 'role': 'CONTACT', 'email': 'Caitlin.Goodman@CommonSpirit.org', 'phone': '602-406-6262'}], 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Corina Lugo', 'role': 'CONTACT', 'email': 'contact-PHX@arensia-em.com', 'phone': '602-693-1183'}], 'facility': 'ARENSIA Exploratory Medicine', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina Diaz', 'role': 'CONTACT', 'email': 'Cdiaz@neurotucson.com', 'phone': '520-320-2157'}], 'facility': 'Center for Neurosciences', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'WRN', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Amicis Research Center', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amineh Ghazarian', 'role': 'CONTACT', 'email': 'amineh.ghazarian@profoundresearch.io', 'phone': '818-450-4393'}], 'facility': 'Profound Research LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Merrill', 'role': 'CONTACT', 'email': 'emma.merrill@medstar.net', 'phone': '202-877-6607'}], 'facility': 'Medstar Health Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Showkat Hossain', 'role': 'CONTACT', 'email': 'showkat.hossain@novaclinicalresearch.com', 'phone': '941-792-6564'}], 'facility': 'Nova Clinical Research, LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': 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'contacts': [{'name': 'Joseph Hilde', 'role': 'CONTACT', 'email': 'jhilde01@knightneurology.com', 'phone': '855-564-4484'}], 'facility': 'Knight Neurology', 'geoPoint': {'lat': 28.35084, 'lon': -80.72533}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Liz Santos', 'role': 'CONTACT', 'email': 'santosresearchcenter@gmail.com', 'phone': '813-249-9100'}], 'facility': 'Santos Research Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Antonio Barreiro', 'role': 'CONTACT', 'email': 'abarreiro@encoremedicalresearch.com', 'phone': '954-777-8827'}], 'facility': 'Encore Medical Research of Weston LLC.', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Han', 'role': 'CONTACT', 'email': 'jhan@hawaiineuroscience.com', 'phone': '808-564-6141'}], 'facility': 'Hawaii Pacific Neuroscience', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Gravett', 'role': 'CONTACT', 'email': 'Lisa@Idahoepilepsy.com', 'phone': '208-275-8585'}], 'facility': 'Consultants in Epilepsy & Neurology, PLLC (CEN)', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irena Bellinski', 'role': 'CONTACT', 'email': 'irena.bellinski@nm.org', 'phone': '312-926-1672'}], 'facility': 'Northwestern Medical 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