NCT01292837

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

An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Epilepsy
• Generalized Tonic-clonic Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam	The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-02-10
• Last updated: 2015-05-15
• Results posted: 2014-08-12

Locations

26 sites across 1 country: Japan