Conditions: Epilepsy
Keywords: Seizures retigabine IR GW582892 Epilepsy Open label, flexible dose Partial-onset seizures
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 203
Healthy volunteers: no

Brief 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.

Detailed description:
This is an open-label, multi-centre, flexible dose study of retigabine immediate release (IR). The study will enroll male and female outpatients (≥ 18 years of age) with partial-onset seizures (POS) who are inadequately controlled on their current monotherapy Antiepileptic Drug (AED). Following a Screening Period of up to 2 weeks, subjects will enter an 8-week Baseline Phase to determine baseline seizure frequency. At the end of the Baseline Phase, subjects who meet or exceed the minimum seizure frequency of 4 partial seizures per 56 days, will enter the Treatment Period (4 weeks Titration, 16 weeks Flexible Dose Evaluation Phase). All subjects will receive retigabine IR starting at 150 mg/day and will be titrated to 600 mg/day by Week 4. From Week 5 onwards, subjects' doses will be maintained between 300 to 1200 mg/day using a flexible dosing regimen to optimise response and tolerability. The maximum duration of the study is approximately 33 weeks (inclusive of a 3 week Taper/Follow-up Phase).

Arms:
arm 1: Open Label flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).

Interventions: intervention 1: Retigabine IR
Intervention descriptions: intervention 1: Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).

Protocol document: