drugset / Trial / NCT01063764

An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

NCT01063764

Phase 3 Completed 73 enrolled UCB Japan Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Timeline

Start
2010-01
Primary completion
2011-04
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 20 mg/kg Oral
Subject Levetiracetam Other / unclassified 40 mg/kg Oral
Subject Levetiracetam Other / unclassified 60 mg/kg Oral
Subject Levetiracetam Other / unclassified 1000 mg Oral
Subject Levetiracetam Other / unclassified 2000 mg Oral
Subject Levetiracetam Other / unclassified 3000 mg Oral

Indications