Official Title: “Open-Label, Single-Arm, Multi-Center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 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 1 month to 4 years.

Study Type: Interventional

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

Study Primary Completion Date: July 2010

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levetiracetam

Primary 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).
  • Time Frame: up to 4 days
    Safety Issue?: No

Secondary Measures

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

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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 4 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

UCB Clinical 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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00505934

Study ID Number: N01275

ClinicalTrials.gov Identifier: NCT00505934

Health Authority: United States: Food and Drug Administration