drugset / Trial / NCT01292837

A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

NCT01292837

Phase 3 Completed 13 enrolled UCB Japan Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).

Timeline

Start
2011-02
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 60 mg/kg Oral
Subject Levetiracetam Other / unclassified 3000 mg Oral