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

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Levetiracetam
Keppra

Study placed in the following topic categories:

Epilepsy
Seizures
Piracetam

Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009