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

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00505934

Run by

UCB Pharma SA

People needed

19

Starts

2008-05-01

Expected to finish

2010-03-01

Last updated by the study team

2015-07-15

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — San Diego, California, United States
• Study site — Buffalo, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Amiens, France
• Study site — Lille, France
• Study site — Paris, France
• Study site — Vandœuvre-lès-Nancy, France
• Study site — Heidelberg, Germany
• Study site — Kehl, Germany
• Study site — Kiel, Germany
• Study site — Torreón, Coahuila, Mexico
• Study site — Puebla City, CP, Mexico
• Study site — Aguascalientes, Mexico
• Study site — Guadalajara, Mexico
• Study site — Mexico City, Mexico
• Study site — Puebla City, Mexico
• Study site — Ankara, Turkey (Türkiye)
• Study site — Izmir, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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