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From the Department of Neurology (S.N.), University of Munich, Germany; Montreal Neurological Institute and Hospital (E.A., F.A.) and the Departments of Neurology and Neurosurgery (E.A., F.A.), Human Genetics (E.A.), and Pediatrics (F.A.), McGill University, Montreal, Quebec, Canada; UCB Pharma SA (P.M.), Braine-l’Alleud, Belgium; Insight Medical Communications Inc. (W.B.G.), New York, NY; and UCB Inc. (J.S.-D.), Atlanta, GA.
Address correspondence and reprint requests to Prof. Soheyl Noachtar, Epilepsy Centre, Department of Neurology, University of Munich, Marchioninistr. 15, 81377 Munich, Germany noa{at}med.uni-muenchen.de
Background: Currently, there are no published randomized controlled trials evaluating the efficacy and safety of adjunctive antiepileptic therapy in idiopathic generalized epilepsy with myoclonic seizures.
Methods: This randomized, double-blind, placebo-controlled multicenter trial assessed the efficacy and tolerability of adjunctive treatment with levetiracetam 3,000 mg/day in adolescents (
12 years) and adults (
65 years) with idiopathic generalized epilepsy, who experienced myoclonic seizures on 8 days during a prospective 8-week baseline period, despite antiepileptic monotherapy. The 8-week baseline period was followed by 4-week up-titration, 12-week evaluation, and 6-week down-titration/conversion periods.
Results: Of 122 patients randomized, 120 (levetiracetam, n = 60; placebo, n = 60) were evaluable. Diagnoses were either juvenile myoclonic epilepsy (93.4%) or juvenile absence epilepsy (6.6%). A reduction of 50% in the number of days/week with myoclonic seizures was seen in 58.3% of patients in the levetiracetam group and in 23.3% of patients in the placebo group (p < 0.001) during the treatment period. Levetiracetam-treated patients were more likely to respond to treatment than patients receiving placebo (OR = 4.77; 95% CI, 2.12 to 10.77; p < 0.001). Levetiracetam-treated patients had higher freedom from myoclonic seizures (25.0% vs 5.0%; p = 0.004) and all seizure types (21.7% vs 1.7%; p < 0.001) during the evaluation period. The only adverse events more frequent with levetiracetam were somnolence and neck pain.
Conclusion: These results suggest that levetiracetam is an effective and well-tolerated adjunctive treatment for patients with previously uncontrolled idiopathic generalized epilepsy with myoclonic seizures.
Abbreviations: AED = antiepileptic drug; HRQoL = health-related quality of life; IGE = idiopathic generalized epilepsy; ILAE = International League Against Epilepsy; ITT = intent to treat; JAE = juvenile absence epilepsy; JME = juvenile myoclonic epilepsy; OR = odds ratio; QoLIE-31-P = patient weighted Quality of Life in Epilepsy questionnaire; TEAE = treatment-emergent adverse event.
Supplemental data at www.neurology.org
*The members of the N166 Study Group are listed in the appendix.
This study was funded by UCB Pharma SA, Braine-l’Alleud, Belgium.
Disclosure: S. Noachtar received speaker and consultancy fees and research and educational grants from UCB Pharma SA, Novartis, Pfizer, Janssen-Cilag, Desitin, Eisai, and Sanofi-Synthelabo. No shares. Clinical trials as principal investigator for Novartis, Pfizer, Janssen-Cilag, Johnson & Johnson, UCB Pharma SA, Desitin, Eisai, and Sanofi-Synthelabo. E. Andermann is presently a consultant for UCB Pharma SA and principal investigator or co-investigator of clinical trials for UCB Pharma SA and Eisai. She has served on the medical advisory boards of and/or received educational and research grants from Pfizer Canada, Novartis, UCB Pharma SA, Oryx Canada, Lundbeck Canada, Glaxo-Welcome Canada, Janssen-Ortho Canada, and Abbott USA. She has previously carried out clinical trials as principal investigator or co-investigator for Pfizer Canada, Glaxo-Welcome Canada, UCB Pharma SA, Ciba-Geigy Canada, and Abbott USA. No shares. F. Andermann is presently principal investigator or co-investigator of clinical trials with UCB Pharma SA and Eisai and consultant to UCB Pharma SA, Glaxo Smith Kline, and Novartis. No shares. P. Meyvisch and J. Schiemann-Delgado are employees of UCB Pharma SA. W.B. Gough is an employee of Insight Medical Communications that drafted and facilitated the manuscript contracted by UCB Pharma SA. He has done similar work with Merck and Johnson & Johnson.
Received October 10, 2006. Accepted in final form July 27, 2007.
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