Status:
COMPLETED
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Seizures
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are re...
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 mg/day, in three equally divided doses, compared with plac...
Eligibility Criteria
Inclusion
- Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
- 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
- Currently treated with up to three established AEDs
- Vagal Nerve Stimulator may be included
Exclusion
- Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
- Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests
- Impaired renal function (creatinine clearance less than 50 mL/minute)
- Evidence of progressive central nervous disease, lesion, or encephalopathy
- History of primary generalized seizures
- History of clustering or flurries or status epilepticus within 12 months of study entry
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00232596
Start Date
September 1 2005
End Date
January 1 2008
Last Update
December 8 2016
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
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