Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 receiving up to three established antiepileptic drugs (AEDs).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Ezogabine

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