A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 4
Updated:4/21/2016
Start Date:October 2004
End Date:January 2007

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A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age. N01009

To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in
pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects
will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an
evaluation). Other neuropsychological clinical assessments will be performed during the 34
day length of the study.


Inclusion Criteria:

- Pediatric patients from 1 month to less than 4 years of age

- Pediatric patients diagnosed with refractory partial onset seizures, on a stable
regimen of one to two other anti-epileptic drugs and at least 2 partial onset
seizures per week in the two weeks prior to screening

- Patients must have two partial onset seizures (with corresponding clinical event)
during the 48-hour video EEG at screening

Exclusion Criteria:

- A ketogenic diet

- Previous exposure to levetiracetam

- Seizures too close together to count accurately

- Treatable seizure etiology

- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing
cerebral disease

- Diagnosis of a terminal illness
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