drugset / Trial / NCT01228747

A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

NCT01228747

Phase 3 Completed 361 enrolled UCB Japan Co. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Timeline

Start
2010-10
Primary completion
2014-04
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 1000 mg Oral
Subject Levetiracetam Other / unclassified 2000 mg Oral
Subject Levetiracetam Other / unclassified 3000 mg Oral