Ignite Creation Date:
2025-12-18 @ 9:20 AM
Ignite Modification Date:
2025-12-18 @ 9:20 AM
Study NCT ID:
NCT00105040
Status:
None
Last Update Posted:
2015-03-02 00:00:00
First Post:
2005-03-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
Sponsor:
None
Organization:
Study Overview
Official Title:
A 19-week, Randomized, Double-blind, Multicenter, Placebo-controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20 - 60 mg/kg/Day, Divided in Twice Daily Dosing, as Adjunctive Treatment in Children 4 - 16 Years Old, Inclusive, With Refractory Partial Onset Seizures
Status:
None
Status Verified Date:
2015-02
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:
A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: