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Levetiracetam (Keppra) Effective in Tough-To-Treat Patients with Idiopathic Generalized Epilepsy and Myoclonic Seizures: Presented at IEC

By Jill Stein

PARIS, FRANCE -- August 30, 2005 -- Levetiracetam (Keppra) decreases the frequency of myoclonic seizures days by 50% or more in nearly two-thirds of children and adult patients with refractory generalized epilepsy and myoclonic seizures, according to phase 3 results reported here on August 29^th at the 26^th International Epilepsy Congress (IEC).

Soheyl Noachtar, MD, Head of the Epilepsy Centre, University of Munich, Munich, Germany, presented results in 121 patients who had been randomized to 12 weeks' treatment with levetiracetam uptitrated to 3000 mg per day or placebo.

Eligible participants in the trial ranged from 12 to 65 years of age and had experienced at least 8 days with myoclonic seizures during the 8-week baseline period and had to be treated with one concomitant anti-epileptic drug.

Seizure activity was reported by patients in a journal and evaluated by the investigators using the International League Against Epilepsy classification.

The primary efficacy measure was the responder rate, defined as a 50% or greater reduction in days with myoclonic seizures during the treatment period versus baseline.

Results showed a responder rate of 58.3% in the levetiracetam group compared with 23.3% in the placebo group (P = .0002), with a corresponding odds ratio of 4.77.

Thirteen levetiracetam-treated patients and two placebo-treated patients were seizure-free during the evaluation period.

Headache was the most common adverse effect, and occurred in 23.3% of placebo and 21.6% of levetiracetam patients.

One placebo patient and two levetiracetam patients withdrew from their treatment at the end of the evaluation period because of adverse side effects.

Dr. Noachtar said the study is the first phase 3 trial of an epileptic drug for myoclonic seizures in patients with idiopathic generalized epilepsy.

In the US, levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

In Europe, Keppra(R) is approved as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization, in patients over 16 years of age. In August, 2005, the European Medicines Agency issued a positive opinion, recommending approval of Keppra(R) as adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalization, in children 4 years of age and older with epilepsy. This positive opinion is currently under consideration by the European Commission.

Based on the results of the present trial, UCB plans to file marketing authorization applications with the regulatory authorities for the use of levetiracetam as adjunctive therapy in the treatment of myoclonic seizures in patients 12 years of age or older with juvenile myoclonic epilepsy.

The study was funded by UCB.


[Presentation title: Efficacy and Safety of Levetiracetam 3000 mg/d as Adjunctive Treatment in Adolescents and Adults Suffering From Idiopathic Generalized Epilepsy With Myoclonic Seizures.]

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