Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
Timeline
- Start
- 2005-12
- Primary completion
- 2008-04
- Completion
- 2008-04
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) vs Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance); p <0.001 NCT00235755 ↗
registry analysis (superiority or other test); Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) vs Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance); p = 0.007 NCT00235755 ↗
registry analysis (superiority or other test); Placebo - DB Phase (Titration Plus Maintenance) vs Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance); p <0.001; Fisher Exact NCT00235755 ↗
registry analysis (superiority or other test); Placebo - DB Phase (Titration Plus Maintenance) vs Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance; p <0.001; Fisher Exact NCT00235755 ↗
Publications
- Background Brodie MJ, Lerche H, Gil-Nagel A, Elger C, Hall S, Shin P, Nohria V, Mansbach H; RESTORE 2 Study Group. Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy. Neurology. 2010 Nov 16;75(20):1817-24. doi: 10.1212/WNL.0b013e3181fd6170. Epub 2010 Oct 13.
- Background Tompson DJ, Crean CS. Clinical pharmacokinetics of retigabine/ezogabine. Curr Clin Pharmacol. 2013 Nov;8(4):319-31. doi: 10.2174/15748847113089990053.
- Background Brickel N, Gandhi P, VanLandingham K, Hammond J, DeRossett S. The urinary safety profile and secondary renal effects of retigabine (ezogabine): a first-in-class antiepileptic drug that targets KCNQ (K(v)7) potassium channels. Epilepsia. 2012 Apr;53(4):606-12. doi: 10.1111/j.1528-1167.2012.03441.x. Epub 2012 Mar 16.
- Porter RJ, Burdette DE, Gil-Nagel A, Hall ST, White R, Shaikh S, DeRossett SE. Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012 Aug;101(1-2):103-12. doi: 10.1016/j.eplepsyres.2012.03.010. Epub 2012 Apr 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezogabine | Small molecule | 600 mg | Oral |
| Subject | Ezogabine | Small molecule | 900 mg | Oral |