TerminatedPhase 2/3

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

Stopped: Sponsor Decision

United States27 participantsStarted 2024-06-20

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. 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).

What they're measuring

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

Trial details

NCT IDNCT06425159

SponsorBiohaven Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-12

View on ClinicalTrials.gov More Generalized Epilepsy trials