A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
NCT ID: NCT00105040
Last Updated: 2015-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2004-09-30
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Levetiracetam (LEV)
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Levetiracetam
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Matching Placebo (PBO)
Oral tablets and oral solution.
Placebo (PB)
Oral tablets and oral solution
Interventions
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Levetiracetam
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Placebo (PB)
Oral tablets and oral solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects should be on a stable regimen of one or a maximum of two other antiepileptic drugs (AEDs) for at least 2 weeks prior to Visit 1
* Subject must have an Intelligence Quotient (IQ) as assessed during Visit 1 of at least 70
* Subject and parent/guardian should be fluent in English
Exclusion Criteria
* Subject is receiving benzodiazepines on a routine or chronic basic and is unable to discontinue use four weeks prior to Visit 1
* Subject has seizures too close together to accurately count
* Subject has a current psychiatric disorder other than mild to moderate attention deficit, behavior, or learning disorders
4 Years
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Voorhees Township, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Scarborough Village, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Bloemfontein, , South Africa
Cape Town, , South Africa
Capitol Park, , South Africa
Johannesburg, , South Africa
Countries
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References
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Levisohn PM, Mintz M, Hunter SJ, Yang H, Jones J; N01103 Levetiracetam Study Group. Neurocognitive effects of adjunctive levetiracetam in children with partial-onset seizures: a randomized, double-blind, placebo-controlled, noninferiority trial. Epilepsia. 2009 Nov;50(11):2377-89. doi: 10.1111/j.1528-1167.2009.02197.x. Epub 2009 Aug 21.
de la Loge C, Hunter SJ, Schiemann J, Yang H. Assessment of behavioral and emotional functioning using standardized instruments in children and adolescents with partial-onset seizures treated with adjunctive levetiracetam in a randomized, placebo-controlled trial. Epilepsy Behav. 2010 Jul;18(3):291-8. doi: 10.1016/j.yebeh.2010.04.017. Epub 2010 May 23.
Other Identifiers
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2014-004396-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01103
Identifier Type: -
Identifier Source: org_study_id
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