At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of refractory epilepsy with simple or complex partial onset seizures (with or without secondary generalization)
- ✓At least 4 partial seizures in 28 days during 8-week baseline phase
- ✓Currently receiving 1-3 established antiepileptic drugs (AEDs)
- ✓Vagal Nerve Stimulator may be included
- ✕Impaired renal function with creatinine clearance <50 mL/minute
- ✕Evidence of progressive central nervous system disease, lesion, or encephalopathy
- ✕History of primary generalized seizures
- ✕Clustering, flurries, or status epilepticus within 12 months of study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 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 539 participants across 70 sites in 13 countries.
Detailed 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).
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 3, patients will enter a 12 week maintenance phase.
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 5, patients will enter a 12 week maintenance phase.
Oral tablet.