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

This study has been completed.

First Received: January 27, 2008 Last Updated: April 16, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00615615

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 III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by UCB:

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

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Publications:

Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z; N159 Study Group. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology. 2006 Jun 13;66(11):1654-60. Epub 2006 Apr 26.

Jensen FE, Bourgeois BF. Randomized trial supports use of levetiracetam adjunctive therapy to treat partial seizures in children. Nat Clin Pract Neurol. 2006 Nov;2(11):596-7. No abstract available.

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N159
Study First Received:	January 27, 2008
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00615615 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Levetiracetam
Keppra

Study placed in the following topic categories:

Nootropic Agents
Epilepsy
Seizures
Piracetam
Central Nervous System Diseases

Etiracetam
Brain Diseases
Neuroprotective Agents
Anticonvulsants

Additional relevant MeSH terms:

Nootropic Agents
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neuroprotective Agents
Protective Agents

Pharmacologic Actions
Epilepsy
Therapeutic Uses
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009