Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097
Status:
Terminated
Trial end date:
2018-05-24
Target enrollment:
Participant gender:
Summary
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind
VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet
inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an
adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.
Treatment will be continued until the subject withdraws from the study or until the program
is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia,
and South Africa. The primary objective of the study is to evaluate the safety and
tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult
epilepsy patients with partial-onset seizures, who completed the double-blind Study
VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with
retigabine and patient quality of life and to evaluate whether retinal pigmentation,
unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of
nails, lips, skin or mucosa change over time after discontinuation of retigabine.