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NEUROLOGY 2007;69:250-254
© 2007 American Academy of Neurology

An open-label trial of levetiracetam in severe myoclonic epilepsy of infancy

P. Striano, MD, A. Coppola, MD, M. Pezzella, MD, C. Ciampa, MD, N. Specchio, MD, F. Ragona, MD, M. M. Mancardi, MD, E. Gennaro, PhD, F. Beccaria, MD, G. Capovilla, MD, P. Rasmini, MD, D. Besana, MD, G. G. Coppola, MD, M. Elia, MD, T. Granata, MD, M. Vecchi, MD, F. Vigevano, MD, M. Viri, MD, R. Gaggero, MD, S. Striano, MD and F. Zara, PhD

From the Epilepsy Center (P.S., A.C., M.P., S.S., C.C.), Federico II University, Napoli; Muscular and Neurodegenerative Disease Unit (P.S., F.Z.) and Epilepsy Unit, Department of Child Neuropsychiatry (M.M.M., R.G.), Institute G. Gaslini, Genova; Neurology Division (N.S., F.V.), Bambino Gesu Children’s Hospital, Rome; Division of Child Neurology (F.R., T.G.), Istituto Nazionale Neurologico "C. Besta," Milan; Laboratory of Genetics (E.G.), E.O. Ospedali Galliera, Genova; Department of Child Neuropsychiatry (F.B., G. Capovilla), Ospedale "C. Poma," Mantova; Child Neuropsychiatry (P.R., D.B.), Alessandria Hospital, Alessandria; Child Neuropsychiatry (G. Coppola), Second University of Napoli; Department of Neurology (M.E.), Oasi Institute for Research on Mental Retardation and Brain Aging, Troina; Pediatric Clinic (M. Vecchi), University of Padova; and Center for Child Epilepsy (M. Viri), A. O. "Fatebenefratelli e Oftalmico," Milan, Italy.

Address correspondence and reprint requests to Dr. Pasquale Striano, Muscular and Neurodegenerative Disease Unit, Institute G. Gaslini, Genova, Epilepsy Center, Department of Neurological Sciences, Federico II University, Napoli, Italy pstriano{at}email.it

Objective: To conduct an open-label, add-on trial on safety and efficacy of levetiracetam in severe myoclonic epilepsy of infancy (SMEI).

Patients and Methods: SMEI patients were recruited from different centers according to the following criteria: age ≥3 years; at least four tonic-clonic seizures/month during the last 8 weeks; previous use of at least two drugs. Levetiracetam was orally administrated at starting dose of approximately 10 mg/kg/day up to 50 to 60 mg/kg/day in two doses. Treatment period included a 5- to 6-week up-titration phase and a 12-week evaluation phase. Efficacy variables were responder rate by seizure type and reduction of the mean number per week of each seizure type. Analysis was performed using Fisher exact and Wilcoxon tests.

Results: Twenty-eight patients (mean age: 9.4 ± 5.6 years) entered the study. Sixteen (57.1%) showed SCN1A mutations. Mean number of concomitant drugs was 2.5. Mean levetiracetam dose achieved was 2,016 mg/day. Twenty-three (82.1%) completed the trial. Responders were 64.2% for tonic-clonic, 60% for myoclonic, 60% for focal, and 44.4% for absence seizures. Number per week of tonic-clonic (median: 3 vs 1; p = 0.0001), myoclonic (median: 21 vs 3; p = 0.002), and focal seizures (median: 7.5 vs 3; p = 0.031) was significantly decreased compared to baseline. Levetiracetam effect was not related to age at onset and duration of epilepsy, genetic status, and concomitant therapy. Levetiracetam was well tolerated by subjects who completed the study. To date, follow-up ranges 6 to 36 months (mean, 16.2 ± 13.4).

Conclusion: Levetiracetam add-on is effective and well tolerated in severe myoclonic epilepsy of infancy. Placebo-controlled studies should confirm these findings.

Editorial, see page 233

Supported by the Italian League against Epilepsy and the Italian Ministry of Health (no. 132/03 to F.Z.).

Disclosure: The authors report no conflicts of interest.

Received January 2, 2007. Accepted in final form March 7, 2007.


Related articles in Neurology:

Understanding and treating a channelopathy: Severe myoclonic epilepsy of infancy
Gregory L. Krauss and Peter F. Morrison
Neurology 2007 69: 233-234. [Full Text]  



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G. L. Krauss and P. F. Morrison
Understanding and treating a channelopathy: Severe myoclonic epilepsy of infancy
Neurology, July 17, 2007; 69(3): 233 - 234.
[Full Text] [PDF]


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