Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175890
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2005-09-09
Brief Title:
A Placebo-controlled Study of Levetiracetam In Children 1mo to 4yrs of Age With Partial Onset Seizures
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Double-Blind Randomized Multicenter Placebo-controlled In-Patient Maximum 34 Day Study of Levetiracetam Oral Solution 20-50 mgkgDay as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age
Status:
COMPLETED
Status Verified Date:
2020-09
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:
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures Subjects will be evaluated with 48 hour inpatient video electroencephalograms a selection and an evaluation Other neuropsychological clinical assessments will be performed during the 34 day length of the study
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-000199-14 | EUDRACT_NUMBER | None | None |