Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-03 @ 2:10 AM
Study NCT ID:
NCT00544050
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2007-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Sponsor:
UCB Pharma
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: