Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03325439
Status:
TERMINATED
Last Update Posted:
2024-04-08
First Post:
2017-10-25
Brief Title:
A Study to Test the Pharmacokinetics Efficacy and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Open-Label Single-Arm Study to Evaluate the Pharmacokinetics Efficacy and Safety of Brivaracetam in Neonates With Repeated Electroencephalographic Seizures
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated The study stopped prematurely due to enrolment challenges the termination was not linked to any safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the pharmacokinetics PK of brivaracetam BRV in neonates who have seizures that are not adequately controlled with previous antiepileptic drug AED treatment and to identify the optimal BRV dose Exploratory Cohort for the treatment of subjects enrolled into the Confirmatory Cohorts of this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-002756-27 | EUDRACT_NUMBER | None | None |