Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma SA
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• Male or female between 1 month and 4 years of age, inclusive

• The subject suffers from epilepsy (except status epilepticus)

• The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time

Exclusion Criteria:

• The subject has difficult venous accessibility

• History of status epilepticus during the 3 months prior to Screening

• The subject is on felbamate with less than 18 months continuous exposure before Screening.

• The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.