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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00175890Tipo: INTERVENTIONALInicio: 1 de oct de 2004Fin estimado: 1 de ene de 2007

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 1 MonthEdad máxima: 4 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Levetiracetam

Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.

other

Placebo

Placebo solution, which is indistinguishable from the Levetiracetam oral solution.

Ubicaciones

Buenos Aires, Argentina

Mendoza, Argentina

Pilar Buenos Aires, Argentina

Patrocinadores

PrincipalUCB Pharma

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