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

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: September 8, 2005
Last updated: November 25, 2013
Last verified: September 2009
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 Intervention Phase
Generalized Convulsive Epilepsy Drug: Levetiracetam Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

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

Estimated Enrollment: 154
Study Start Date: September 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult)
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.
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Please refer to this study by its identifier: NCT00160550

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications: Identifier: NCT00160550     History of Changes
Other Study ID Numbers: N01057
Study First Received: September 8, 2005
Last Updated: November 25, 2013

Keywords provided by UCB Pharma:
Idiopathic Generalized Epilepsy, tonic-clonic seizures
Levetiracetam, Keppra

Additional relevant MeSH terms:
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on August 16, 2017