drugset / Trial / NCT00291655

Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

NCT00291655

Phase 3 Completed 130 enrolled UCB Pharma
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-06
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 1000 mg Oral
Subject Levetiracetam Other / unclassified 3000 mg Oral

Indications