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OpenTrials
Completed

NCT Number: NCT00160550

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

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.

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Key information

Conditions

Generalized Convulsive Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Epilepsy, Idiopathic Generalized Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

4 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

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

Secondary outcomes

  1. Reduction during the Treatment Period in PGTC seizure frequency

  2. Percentage reduction during the Treatment Period in seizure days

  3. Responder rates in PGTC seizure frequency, and in seizure days of all types.

  4. The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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