Abstract | OBJECTIVE: METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial in adults with ≥4 partial-onset seizures per month receiving 1 to 3 antiepileptic drugs. EZG (RTG) or placebo, 3 times daily, was titrated to 600 or 900 mg/d over 4 weeks, and continued during a 12-week maintenance phase. Median percentage seizure reductions from baseline and responder rates (≥50% reduction in baseline seizure frequency) were assessed. RESULTS: The intention-to-treat population comprised 538 patients (placebo, n = 179; 600 mg, n = 181; 900 mg, n = 178), 471 of whom (placebo, n = 164; 600 mg, n = 158; 900 mg, n = 149) entered the maintenance phase. Median percentage seizure reductions were greater in EZG (RTG)-treated patients (600 mg, 27.9%, p = 0.007; 900 mg, 39.9%, p < 0.001) compared with placebo (15.9%). Responder rates were higher in EZG (RTG)-treated patients (600 mg, 38.6%, p < 0.001; 900 mg, 47.0%, p < 0.001) than with placebo (18.9%). Treatment discontinuations due to adverse events (AEs) were more likely with EZG (RTG) than with placebo (placebo, 8%; 600 mg, 17%, 900 mg, 26%). The most commonly reported (>10%) AEs in the placebo, EZG (RTG) 600 mg/d, and EZG (RTG) 900 mg/d groups were dizziness (7%, 17%, 26%), somnolence (10%, 14%, 26%), headache (15%, 11%, 17%), and fatigue (3%, 15%, 17%). CONCLUSIONS: In this dose-ranging, placebo-controlled trial, adjunctive EZG (RTG) was effective and generally well tolerated in adults with refractory partial-onset seizures. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that adjunctive EZG/RTG reduces the occurrence of partial-onset seizures.
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Authors | M J Brodie, H Lerche, A Gil-Nagel, C Elger, S Hall, P Shin, V Nohria, H Mansbach, RESTORE 2 Study Group |
Journal | Neurology
(Neurology)
Vol. 75
Issue 20
Pg. 1817-24
(Nov 16 2010)
ISSN: 1526-632X [Electronic] United States |
PMID | 20944074
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Carbamates
- Phenylenediamines
- ezogabine
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Topics |
- Adult
- Anticonvulsants
(administration & dosage, adverse effects)
- Carbamates
(administration & dosage, adverse effects, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Epilepsies, Partial
(diagnosis, drug therapy)
- Female
- Humans
- Male
- Middle Aged
- Outcome Assessment, Health Care
- Phenylenediamines
(administration & dosage, adverse effects, therapeutic use)
- Prospective Studies
- Treatment Outcome
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