Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175903
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2005-09-09
Brief Title:
Levetiracetam Versus Standard Antiepileptic Drugs Carbamazepine and Valproate Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Therapeutic Confirmatory Open-label Multi-center Randomized 2 Parallel Groups Community-based Trial Studying the Efficacy and Safety of Levetiracetam 1000 to 3000 mgDay Oral Tablets 250-500 mg bid Compared to Sodium Valproate 1000 to 2000 mgDay Oral ER Tablets 300-500 mg bid and Carbamazepine 600 to 1600 mgDay Oral CR Tablets 200-400 mg bid as Monotherapy in Subjects With Newly Diagnosed Epilepsy
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Study N01175 was to compare overall effectiveness efficacy and safety of levetiracetam LEV versus the 2 older antiepileptic drugs AEDs sodium valproate extended release VPA-ER and carbamazepine controlled release CBZ-CR in the treatment of subjects with newly diagnosed epilepsy
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 |
|---|---|---|---|
| 2004-001339-41 | EUDRACT_NUMBER | None | None |