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

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00160550

Collaborator

(none)

154

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Generalized Convulsive Epilepsy	Drug: Levetiracetam	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Official Title:

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.

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 65 Years

Sexes Eligible for Study:

All

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.