An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

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

Details

• Lead Sponsor: UCB Japan Co. Ltd.
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months

• The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period

• Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion Criteria:

• The patient has a treatable seizure etiology

• The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases

• The patient has a history of status Epilepticus during the 3 months prior to Visit 1

• The patient has a past and present history of pseudo seizures

• The patient has a current diagnosis of Lennox-Gastaut syndrome