Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy

Launched by GLAXOSMITHKLINE · Oct 6, 2005

Keywords

ClinConnect Summary

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 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 seizure frequency for four weeks from baseline to the ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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