A Phase 2/3 interventional study of BHV-7000 and Placebo in Generalized Epilepsy, sponsored by Biohaven Therapeutics Ltd.. Terminated at 109 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Biohaven Therapeutics Ltd. · Phase 2/3, Interventional, and Treatment
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.
35 studies on the registry are indexed under Epilepsy, Idiopathic Generalized; 4 are open to participants now.
This study's enrollment of 27 is below the median of 71 across 26 interventional studies indexed under Epilepsy, Idiopathic Generalized.
Browse Epilepsy, Idiopathic Generalized studies →Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Epilepsy, Idiopathic Generalized, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epilepsy, Generalized. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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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.
Exclusion Criteria:
Drug: BHV-7000
Drug: Placebo
BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily
Matching placebo taken once daily
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
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
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.
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
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
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
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.
Time frame: Baseline to Week 24 of Double-Blind Treatment Period
Showing the first 100 of 109 sites across 14 countries. Choose a country and city above to see the rest.
Ran from Jun 2024 to primary completion in Mar 2026, 20 months.
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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Opakalim
Epilepsy, Idiopathic Generalized →
Biohaven Therapeutics Ltd.