Back to resultsPharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Keppra
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544050
Brief Title
Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Levetiracetam, Keppra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Primary Outcome Measure Information:
Title
PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17442002
Citation
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.
Results Reference
background
Learn more about this trial
Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
We'll reach out to this number within 24 hrs