Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy
2 other identifiers
interventional
19
6 countries
23
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 1 month to 4 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2008
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
February 25, 2011
CompletedJuly 15, 2015
June 1, 2015
1.8 years
July 20, 2007
January 28, 2011
June 22, 2015
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 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) 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 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).
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
Study Sites (23)
Unknown Facility
San Diego, California, 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
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Amiens, France
Unknown Facility
Lille, France
Unknown Facility
Paris, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Heidelberg, Germany
Unknown Facility
Kehl, Germany
Unknown Facility
Kiel, 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 Publications (1)
Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. doi: 10.1177/0883073813480241. Epub 2013 Mar 26.
PMID: 23533164RESULT
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
July 20, 2007
First Posted
July 25, 2007
Study Start
May 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 15, 2015
Results First Posted
February 25, 2011
Record last verified: 2015-06