Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160550
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2005-09-08
Brief Title:
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Double-blind Multicenter Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mgDay Pediatric Target Dose of 60 mgkgDay Oral Levetiracetam LEV 166 250 and 500mg Tablets in Adult and Pediatric Subjects 4-65 Years Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic PGTC Seizures
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:
This study will assess the efficacy safety and tolerability of adjunctive treatment with LEV 3000 mgday or a target dose of 60 mgkgday in children compared to placebo in reducing PGTC seizures in subjects 4 - 65 years suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs
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