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

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy, Partial

Treatments

Drug: Levetiracetam

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00175890

N01009

2004-000199-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

116 patients

Sex

All

Ages

1 month to 4 years old

Volunteers

No Healthy Volunteers

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