A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures

Completed · Phase 2 · Has a placebo group

Conditions studied: Epilepsy, Partial

In brief

A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.

Key facts

Study ID

NCT00105040

Run by

UCB Pharma

People needed

87

Starts

2004-09-01

Expected to finish

2007-03-01

Last updated by the study team

2015-03-02

Who can join

Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric subjects (4 - 16 years old) diagnosed with refractory partial onset seizures for a minimum of six months prior to Visit 1 experiencing at least two partial onset seizures during the four weeks prior to Visit 1 will be enrolled
• 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

You may not qualify if…

• Subject must not have had previous treatment with levetiracetam unless, in the opinion of the investigator, the subject's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of levetiracetam was confounded by concomitant medication
• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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