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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160550

Enrollment

154

Registered

2005-09-12

Start date

2001-09-30

Completion date

2005-06-30

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Convulsive Epilepsy

Keywords

Idiopathic Generalized Epilepsy, tonic-clonic seizures, Levetiracetam, Keppra

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.

Interventions

DRUGLevetiracetam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

4 Years to 65 Years

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.

Design outcomes

Primary

Measure	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

Measure	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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026