Status:
COMPLETED
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Lead Sponsor:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who...
Detailed Description
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and excl...
Eligibility Criteria
Inclusion
- Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures
- Patient is expected to benefit from participation in the study in the opinion of the Investigator.
Exclusion
- Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.
- Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
- Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2017
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00310375
Start Date
May 1 2006
End Date
March 15 2017
Last Update
July 31 2020
Active Locations (51)
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1
University of Alabama -- Department of Neurology/Epilepsy Center
Birmingham, Alabama, United States, 35294
2
North Alabama Neuroscience Research Associates
Huntsville, Alabama, United States, 35801
3
Neurology Clinic
Northport, Alabama, United States, 35476
4
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013