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

Study Overview
=================
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.

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.

Conditions
-----------------
Generalized Convulsive Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Generalized Epilepsy, tonic-clonic seizures, Levetiracetam, Keppra