Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
Generalized Epilepsy
About this trial
This is an interventional treatment trial for Generalized Epilepsy focused on measuring Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam
Eligibility Criteria
Inclusion Criteria: Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV) Subjects who were/are suffering from primary generalized (type II) epileptic seizures Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected Exclusion Criteria: Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol Concomitant use of any drug with possible central nervous system effects unless at a stable dose Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
Sites / Locations
Arms of the Study
Arm 1
Experimental
Levetiracetam
Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).