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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508812-45-00

Acronym

BHV7000-304

Enrollment

122

Registered

2024-10-07

Start date

2024-11-11

Completion date

Unknown

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures

Brief summary

Time to the second day with a GTC seizure during the double-blind phase.

Detailed description

- Proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan-Meier methods. - Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs, and grade 3 and grade 4 laboratory abnormalities.

Interventions

DRUGBHV-7000

DRUGPlacebo for BHV-7000

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to the second day with a GTC seizure during the double-blind phase.	—

Secondary

Measure	Time frame
- Proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan-Meier methods. - Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs, and grade 3 and grade 4 laboratory abnormalities.	—

Countries

Austria, Belgium, Croatia, Finland, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026