Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 7:59 PM
Study NCT ID:
NCT05109234
Status:
COMPLETED
Last Update Posted:
2025-10-22
First Post:
2021-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Sponsor:
UCB Biopharma SRL
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Status:
COMPLETED
Status Verified Date:
2025-10
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:
None
Brief Summary:
The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-002769-33 | EUDRACT_NUMBER | None | View |