Status:
COMPLETED
Retigabine Efficacy and Safety Trial 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 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epile...
Detailed Description
This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided dose...
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 :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
539 Patients enrolled
Trial Details
Trial ID
NCT00235755
Start Date
December 1 2005
End Date
April 1 2008
Last Update
April 21 2017
Active Locations (70)
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1
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
2
Neurological Clinic-Texas
Dallas, Texas, United States, 75230
3
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
4
North Coast Neurology Centre
Maroochydore, Queensland, Australia, 4558