Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-30 @ 9:22 PM
Study NCT ID:
NCT01921205
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2013-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
Sponsor:
UCB Pharma
Organization:
Study Overview
Official Title:
A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Years of Age With Partial Onset Seizures
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03559673
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures.
Detailed Description:
The primary objective of this study is to evaluate the efficacy of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures.
The secondary objective is to evaluate the safety and tolerability of LCM in subjects ≥4 years to \<17 years of age.
An additional objective is to evaluate the pharmacokinetics (PK) of LCM in subjects ≥4 years to \<17 years of age.
The secondary objective is to evaluate the safety and tolerability of LCM in subjects ≥4 years to \<17 years of age.
An additional objective is to evaluate the pharmacokinetics (PK) of LCM in subjects ≥4 years to \<17 years of age.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| 2012-004996-38 | EUDRACT_NUMBER | None | View |