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Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00615615
First received: January 27, 2008
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.


Condition Intervention Phase
Epilepsy
 Drug: Levetiracetam
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Partial onset seizure frequency per week during the treatment period. [ Time Frame: collection of seizure count throughout the whole study (baseline and treatment periods) ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Collection of safety data throughout the whole study period ]

Enrollment: 216
Study Start Date: September 1999
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit;
  • epilepsy was classifiable according to the ILAE Classification;
  • >= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization;
  • unsatisfactory current AED treatment in terms of efficacy and/or safety;
  • stable AED treatment consisting of no more than two AEDs.

Exclusion Criteria:

  • treatable seizure etiology;
  • epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases;
  • history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit;
  • history of or the presence of pseudo seizures;
  • current diagnosis of Lennox-Gastaut syndrome.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615615

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Publications:

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00615615     History of Changes
Other Study ID Numbers: N159
Study First Received: January 27, 2008
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 June 18, 2013