Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.
2 other identifiers
interventional
33
6 countries
25
Brief 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 4 to 16 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2007
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 25, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
February 25, 2011
CompletedAugust 31, 2011
March 1, 2011
2.4 years
September 25, 2007
January 28, 2011
August 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Treatment period (up to 4 days)
Secondary Outcomes (2)
Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)
Treatment period (up to 4 days)
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Treatment period (up to 4 days)
Study Arms (1)
Levetiracetam
EXPERIMENTALInterventions
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. Dosage for subjects not on levetiracetam at study entry was based on weight: if \<50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).
Eligibility Criteria
You may qualify if:
- 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 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 visit 1.
- The subject is taking felbamate at visit 1 or has been taking it in the past.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (25)
Unknown Facility
La Jolla, California, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Chesterfield, Missouri, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Amiens, France
Unknown Facility
Lille, France
Unknown Facility
Paris, France
Unknown Facility
Heidelberg, Germany
Unknown Facility
Kehl, Germany
Unknown Facility
Torreón, Coahuila, Mexico
Unknown Facility
Puebla City, CP, Mexico
Unknown Facility
Aguascalientes, Mexico
Unknown Facility
Guadalajara, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Puebla City, Mexico
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Izmir, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2007
First Posted
September 26, 2007
Study Start
September 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 31, 2011
Results First Posted
February 25, 2011
Record last verified: 2011-03