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

Phase 3

Completed

• Conditions: Generalized Convulsive Epilepsy

• Registration Number: NCT00160550
• Lead Sponsor: UCB Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2009-09
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
• Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
• Absence of brain lesion documented on a CT scan or MRI.
• An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
• Male/female subject, >=4 or <=65 years of age at Visit 1.
• Subject on a stable dose of one or two AEDs during baseline.

Exclusion Criteria

• Previous exposure to levetiracetam.
• History of partial seizures.
• History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).

Secondary Outcome Measures

Name	Time	Method
Reduction during the Treatment Period in PGTC seizure frequency
Percentage reduction during the Treatment Period in seizure days
Responder rates in PGTC seizure frequency, and in seizure days of all types.
The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations