Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults

Inclusion Criteria:

• Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsyexperiencing myoclonic seizures (IIB) that are classifiable according to theInternational Classification of Epileptic Seizures. To ensure an idiopathicgeneralized epilepsy population, only these subjects with the diagnosis of juvenilemyoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalizedtonic- clonic seizures on awakening must be included.

• Presence of at least eight days with at least one myoclonic seizure (IIB) per dayduring the eight weeks of the Baseline period.

• Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has notbeen performed within the past five years before Visit 1, a CT scan (or MRI wherelegally required) should be performed during the Baseline period.

• Presence of EEG features consistent with idiopathic generalized epilepsy on an EEGrecorded during the Baseline period or no more than one year before Visit 1.

• Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1.

• Subject on a stable dose of one standard anti-epileptic treatment for at least fourweeks before Visit 1.

Exclusion Criteria:

• Previous exposure to levetiracetam.

• History of partial seizures.

• History of convulsive or non-convulsive status epilepticus within 3 months prior toVisit 1.

• Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 monthsexposure, and subject under vagal nerve stimulation or ketogenic diet.

• Subject taking any drug (except the concomitant AEDs) with possible CNS effects.