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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06425159
Other study ID # BHV7000-304
Secondary ID 2023-508812-45-0
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2024
Est. completion date July 2027

Study information

Verified date June 2024
Source Biohaven Pharmaceuticals, Inc.
Contact Chief Medical Officer
Phone 203-404-0410
Email clinicaltrials@biohavenpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 242
Est. completion date July 2027
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male and Female participants 18 to 75 years of age at time of consent. - 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. 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 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). - 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. - Ability of subject or caregiver to keep accurate seizure diaries - Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.). - 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. Exclusion Criteria: - 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. - History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase. - Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Study Design


Intervention

Drug:
BHV-7000
BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily
Placebo
Matching placebo taken once daily

Locations

Country Name City State
United States Dent Neurosciences Research Center Amherst New York
United States OLOLRMC Baton Rouge Louisiana
United States Nova Clinical Research, LLC Bradenton Florida
United States OnSite Clinical Solutions Charlotte North Carolina
United States WR-ClinSearch Chattanooga Tennessee
United States Neurology Consultants of Dallas, PA Dallas Texas
United States Revive Research Institute, Inc. Elgin Illinois
United States Hawaii Pacific Neuroscience Honolulu Hawaii
United States UTHealth Houston Houston Texas
United States University of Florida (Jacksonville) Jacksonville Florida
United States Bluegrass Epilepsy Research Lexington Kentucky
United States Inst of Neurology Livingston New Jersey
United States Vanderbilt University Medical Center Nashville Tennessee
United States Research Institute of Orlando Orlando Florida
United States Profound Research LLC Pasadena California
United States ARENSIA Exploratory Medicine Phoenix Arizona
United States Revive Research Institute, Inc. Rochester Hills Michigan
United States Knight Neurology Rockledge Florida
United States Center for Neurosciences Tucson Arizona
United States Encore Medical Research of Weston LLC. Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Biohaven Therapeutics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period 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 Baseline to Week 24 of Double-Blind Treatment Period
Secondary Percentage of Participants with freedom of GTC seizures during DBT Phase 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. Baseline to Week 24 of Double-Blind Treatment Period
Secondary Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs 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 Baseline to Week 24 of Double-Blind Treatment Period
Secondary Number of Participants With Clinically Significant Laboratory Abnormalities 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. Baseline to Week 24 of Double-Blind Treatment Period
See also
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Terminated NCT03955432 - Long-term Cardiac Monitoring in Epilepsy N/A
Completed NCT00150735 - Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy Phase 3
Recruiting NCT03457961 - Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong
Withdrawn NCT03368469 - Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression N/A
Completed NCT03590197 - Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy Phase 4
Completed NCT00001325 - Metabolic Abnormalities in Children With Epilepsy N/A