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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Pharmaceutical Solutions; Piracetam

Criteria

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