Randomized, double-blind, placebo-controlled trial of ezogabine (retigabine) in partial epilepsy

Randomized, double-blind, placebo-controlled trial of ezogabine (retigabine) in partial epilepsy

Author French, Jacqueline A. Google Scholar
Abou-Khalil, Bassel W. Google Scholar
Leroy, Robert F. Google Scholar
Yacubian, Elza Márcia Targas Autor UNIFESP Google Scholar
Shin, Paul Google Scholar
Hall, Susan Google Scholar
Mansbach, Harry Google Scholar
Nohria, Virinder Google Scholar
RESTORE 1 Study 301 Investigators Google Scholar
Institution NYU
Vanderbilt Univ
Neurol Clin Texas
Universidade Federal de São Paulo (UNIFESP)
Valeant Pharmaceut Int
Mercer Univ
Abstract Objective: To evaluate the efficacy and safety of ezogabine (United States adopted name)/retigabine (international nonproprietary name) (EZG[RTG]) 1,200 mg/day as adjunctive treatment in adults with drug-resistant epilepsy with partial-onset seizures with or without secondary generalization.Methods: RESTORE 1 was a multicenter, randomized, double-blind, parallel-group trial. Following a prospective 8-week baseline phase, patients entered an 18-week double-blind treatment period (6-week forced dose titration to EZG[RTG] 1,200 mg/day in 3 equally divided doses or placebo, followed by a 12-week maintenance phase). Results were analyzed on an intent-to-treat basis for the entire 18-week period and for patients reaching the maintenance phase.Results: In 306 patients randomized, 305 received EZG(RTG) 1,200 mg/day (n = 153) or placebo (n = 152). Median percent reduction in total partial-seizure frequency was 44.3% vs 17.5% (p < 0.001) for EZG(RTG) and placebo, respectively, during the 18-week double-blind period; responder rates (>= 50% reduction in total partial-seizure frequency from baseline) were 44.4% vs 17.8% (p < 0.001). In 256 patients (EZG[RTG], 119; placebo, 137) entering the 12-week maintenance phase, median percent reduction in seizure frequency for EZG(RTG) vs placebo was 54.5% and 18.9% (p < 0.001), respectively; responder rates were 55.5% vs 22.6% (p < 0.001). The proportion of patients discontinuing due to treatment-emergent adverse events (TEAEs) was 26.8% (EZG[RTG]) vs 8.6% (placebo). Dizziness, somnolence, fatigue, confusion, dysarthria, urinary tract infection, ataxia, and blurred vision were the most common TEAEs reported by more patients treated with EZG(RTG) than placebo.Conclusions: This study demonstrates that EZG(RTG) is effective as add-on therapy for reducing seizure frequency in patients with drug-resistant partial-onset seizures.Classification of evidence: This study provides Class II evidence that EZG(RTG) 1,200 mg/day is effective as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. Neurology (R) 2011;76:1555-1563
Language English
Sponsor Valeant Pharmaceuticals International, Aliso Viejo, CA, USA
Valeant Pharmaceuticals International
Kyowa Hakko Kirin Pharma, Inc.
Eisai Inc.
Johnson Johnson
Epilepsy Therapy Development Project
SK Bio-Pharmaceuticals
Vertex Pharmaceuticals
Pfizer Inc.
Merck Serono
Epilepsy Research Foundation
Cyberonics, Inc.
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Jazz Pharmaceuticals
Ovation Pharmaceuticals
Endo Pharmaceuticals
Bial Pharmaceuticals
Neuro-Vista Corporation
Icagen, Inc.
Supernus Pharmaceuticals, Inc.
Ikano Therapeutics Inc.
NeuroTherapeutics Pharma, Inc.
Sepracor Inc.
Marinus Pharmaceuticals, Inc.
Ortho McNeill
Schwartz Biomedical
Lundbeck Inc. (Ovation)
King Pharmaceuticals
Sepacor Inc.
Date 2011-05-01
Published in Neurology. Philadelphia: Lippincott Williams & Wilkins, v. 76, n. 18, p. 1555-1563, 2011.
ISSN 0028-3878 (Sherpa/Romeo, impact factor)
Publisher Lippincott Williams & Wilkins
Extent 1555-1563
Origin http://dx.doi.org/10.​1212/​WNL.​0b013e3182194bd3
Access rights Closed access
Type Article
Web of Science ID WOS:000290150800007
URI http://repositorio.unifesp.br/11600/45019

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