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:
Biohaven Therapeutics Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-508812-45-00 | OTHER | EU CTR | View |