At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
Retigabine IRdrug
Likely dose
Retigabine IR 50 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.
A Multicentre, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures (Extension of Study RTG114855)
In Brief
A Phase 3 clinical trial evaluating Retigabine IR for Epilepsy. Completed, enrolled 30 participants across 12 sites in 3 countries.
Detailed Summary
This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant partial-onset seizures (POS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesMalaysia, South Korea, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartApr 2013
Primary CompletionDec 2016
Study CompletionSep 2017
TodayJul 2026
First PostedJan 28, 2013
Enrollment StartApr 11, 2013
Primary CompletionDec 14, 2016
Study CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.4 years ago
Interventions
Retigabine IRdrug
Retigabine IR tablets will be available in 5 strengths: 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg.