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

NCT00505934 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-07-15

Study results available

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.

Conditions

Epilepsy

Interventions

DRUG

Levetiracetam

Intravenous 100 mg/mL, twice a day, maximum of 4 days Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:. * Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily); * Ages ≥ 6 months to \< 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily). For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows: * Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (7 mg/kg twice daily). * Ages ≥ 6 months to \< 4 years: 20 mg/kg/day (10 mg/kg twice daily).

Sponsors & Collaborators

UCB Pharma SA
lead INDUSTRY

Principal Investigators

UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 1 Month
Max Age: 4 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2008-05-31
Primary Completion: 2010-03-31
Completion: 2010-03-31

Countries

United States
Belgium
France
Germany
Mexico
Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Levetiracetam

Diseases

Epilepsy