At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 203 enrolled
Drug / intervention
Retigabine IRdrug
Likely dose
Retigabine IR 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial -Onset Seizures
In Brief
A Phase 3 clinical trial evaluating Retigabine IR for Epilepsy. Completed, enrolled 203 participants across 66 sites in 12 countries.
Detailed Summary
The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Bulgaria, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Thailand, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedOct 2010
Primary CompletionDec 2012
TodayJul 2026
First PostedOct 25, 2010
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.7 years ago
Interventions
Retigabine IRdrug
Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).