CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 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.

Search/NCT01336621
NCT01336621Phase 3Completed
CompareCT.gov

A Multicentre, Open-Label, Long-Term, Safety and Tolerability Study of Retigabine Immediate Release (IR) in Adults With Partial-Onset Seizures (Extension of Study RGB113905)

GlaxoSmithKline·interventional·Posted Apr 18, 2011·Updated Mar 11, 2020

In Brief

A Phase 3 clinical trial evaluating Retigabine IR for Epilepsy. Completed, enrolled 98 participants across 31 sites in 10 countries.

Detailed Summary

The purpose of this Phase III study is to assess the long-term safety, tolerability and efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult subjects with partial-onset seizures. In addition, those subjects who successfully completed 20 weeks of adjunctive treatment with retigabine IR in the parent study, RGB113905, and who were thought to have benefitted from treatment will be provided continued access to retigabine IR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Bulgaria, France, Germany, Italy, Netherlands, Poland, Russia, Thailand, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 18, 2011
Enrollment StartFeb 21, 2011
Primary CompletionDec 14, 2016
Study CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.2 years ago

Interventions

Retigabine IRdrug

Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum)