Conditions: Epilepsy
Keywords: NEWLY DIAGNOSED EPILEPSY LEVETIRACETAM KEPPRA N01175 (NCT00175903)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 130
Healthy volunteers: no

Brief summary:
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study

Protocol document: