Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422422
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2007-01-10
Brief Title:
Open-label Pharmacokinetic Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
Open-Label Single-Arm Multicenter Pharmacokinetic Safety and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From 1 Month to 16 Years Old With Epilepsy
Status:
COMPLETED
Status Verified Date:
2016-11
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:
Initial study in children with epilepsy to evaluate the pharmacokinetics safety tolerability and preliminary efficacy of adjunctive treatment with brivaracetam and to develop dosing adaptations for future studies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-006536-22 | EUDRACT_NUMBER | None | None |