Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-30 @ 12:36 AM
Study NCT ID:
NCT01339559
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2011-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Sponsor:
UCB BIOSCIENCES, Inc.
Organization:
Study Overview
Official Title:
An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03532516
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
BRITE™
Brief Summary:
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
Detailed Description:
The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| 2010-020345-27 | EUDRACT_NUMBER | None | View |