Overview

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

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 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).
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