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.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00160550
First received: September 8, 2005
Last updated: November 25, 2013
Last verified: September 2009
  Purpose

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)
  Eligibility

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160550

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00160550     History of Changes
Other Study ID Numbers: N01057
Study First Received: September 8, 2005
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration
Mexico: National Institute of Public Health, Health Secretariat
Russia: Pharmacological Committee, Ministry of Health
Canada: Health Canada
Poland: Ministry of Health
Estonia: The State Agency of Medicine
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Food Safety Authority

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

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014