Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
1 other identifier
interventional
13
0 countries
N/A
Brief Summary
The primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month to less than 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 Sep 2002
Shorter than P25 for phase_2
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, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 15, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedNovember 15, 2013
September 1, 2009
8 months
October 15, 2007
November 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
Interventions
Eligibility Criteria
You may qualify if:
- male or female between 1 month and less than 4 years
- diagnosis of any type of epilepsy
- at least 5 kg body weight
- using no more than two antieplieptic drugs
You may not qualify if:
- a treatable seizure etiology
- epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease
- history of status epilepticus during the 2 weeks prior to the Selection Visit
- history of or the presence of pseudoseizures
- epilepsy surgery within one year prior to the Selection Visit
- on a ketogenic diet
- taking felbamate at the Selection Visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Related Publications (1)
Glauser TA, Mitchell WG, Weinstock A, Bebin M, Chen D, Coupez R, Stockis A, Lu ZS. Pharmacokinetics of levetiracetam in infants and young children with epilepsy. Epilepsia. 2007 Jun;48(6):1117-22. doi: 10.1111/j.1528-1167.2007.01090.x. Epub 2007 Apr 18.
PMID: 17442002BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 15, 2007
First Posted
October 16, 2007
Study Start
September 1, 2002
Primary Completion
May 1, 2003
Study Completion
May 1, 2003
Last Updated
November 15, 2013
Record last verified: 2009-09