NCT00160550

Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures

A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Pediatric Subjects (4-65 Years) Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic (PGTC) Seizures.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (planned)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: —

Summary

This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.

Conditions

• Generalized Convulsive Epilepsy

Interventions

Type	Name	Description
DRUG	Levetiracetam

Timeline

• Start date: 2001-09-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2005-09-12
• Last updated: 2013-11-26