Official Title: “Open-Label, Single-Arm, Multi-Center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.”

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 pharmacokinetics, safety and tolerability of this formulation in children aged 4 to 16 years.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam
  • Intravenous 100 mg/mL, BID, maximum 4 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• The concentration of levetiracetam in plasma and saliva samples.
  • Time Frame: up to 4 days
    Safety Issue?: No

Secondary Measures

• Adverse events, local tolerability at the site of infusion, body weight, vital signs, 12-lead ECG recordings, physical and neurological examinations, laboratory tests (blood-hematology and biochemistry), plasma concentrations of anti epileptic drugs.
  • Time Frame: up to 4 days
    

Inclusion Criteria:

• Male or female between 4 and 16 years of age, inclusive.
• The subject suffers from epilepsy (except status epilepticus)
• The subject is requiring levetiracetam IV treatment for a short period of time

Exclusion Criteria:

• The subject has difficult venous accessibility
• History of status epilepticus during the 3 months prior to V1.
• The subject is taking felbamate at V1 or has been taking it in the past.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clnical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Overall Contact: UCB Clinical Trial Call Center +1 877 822 9493 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535392

Study ID Number: N01274

ClinicalTrials.gov Identifier: NCT00535392

Health Authority: United States: Food and Drug Administration