Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232596
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2005-09-30
Brief Title:
Retigabine Adjunctive Therapy Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine 1200 mgDay Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE1
Brief Summary:
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mgday in three equally divided doses compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs AEDs
Detailed Description:
This Phase 3 study is being conducted in North America Argentina and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mgday in three equally divided doses compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs AEDs The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period The proportion of responders greater than or equal to 50 reduction in total partial seizure frequency for four weeks from baseline to the double-blind period will also be evaluated
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