At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of refractory epilepsy with simple or complex partial onset seizures, with or without secondary generalization
- ✓28-day partial seizure frequency of at least 4 seizures during 8-week baseline phase
- ✓Currently treated with up to three established antiepileptic drugs (AEDs)
- ✓Vagal Nerve Stimulator may be included
- ✕Evidence of progressive central nervous system disease, lesion, or encephalopathy
- ✕Impaired renal function with creatinine clearance less than 50 mL/minute
- ✕History of primary generalized seizures
- ✕History of clustering, flurries, or status epilepticus within 12 months of study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
In Brief
A Phase 3 clinical trial evaluating Retigabine and Placebo for Seizures. Completed, enrolled 306 participants across 54 sites in 5 countries.
Detailed 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).
Study Details
Timeline
Interventions
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase
Oral tablet.