Journal
NEUROLOGY
Volume 76, Issue 18, Pages 1555-1563Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e3182194bd3
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Funding
- Valeant Pharmaceuticals International, Aliso Viejo, CA, USA
- GlaxoSmithKline
- Valeant Pharmaceuticals International
- UCB
- Kyowa Hakko Kirin Pharma, Inc.
- Eisai Inc.
- Johnson Johnson
- Epilepsy Therapy Development Project
- FACES
- SK Bio-Pharmaceuticals
- Vertex Pharmaceuticals
- Pfizer Inc.
- Merck Serono
- NIH
- Epilepsy Research Foundation
- Cyberonics, Inc.
- SCHWARZ PHARMA
- Ortho-McNeil-Janssen Pharmaceuticals, Inc.
- Jazz Pharmaceuticals
- Ovation Pharmaceuticals
- Endo Pharmaceuticals
- Bial Pharmaceuticals
- Neuro-Vista Corporation
- Icagen, Inc.
- Supernus Pharmaceuticals, Inc.
- Ikano Therapeutics Inc.
- TaroPharma
- NeuroTherapeutics Pharma, Inc.
- Sepracor Inc.
- Novartis
- Marinus Pharmaceuticals, Inc.
- Ortho McNeill
- Abbott
- Schwartz Biomedical
- LLC.
- Lundbeck Inc. (Ovation)
- King Pharmaceuticals
- Sepacor Inc.
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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
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