Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390221
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2006-10-17
Brief Title:
Safety and Efficacy Study of Daclizumab High Yield Process DAC HYP to Treat Relapsing-Remitting Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Multicenter Double-Blind Placebo-Controlled Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP DAC HYP as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2016-05
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:
SELECT
Brief Summary:
The primary objective of this study is to determine whether DAC HYP when compared to placebo is effective in reducing the rate of relapses between baseline and Week 52 The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium Gd-enhancing lesions reducing the number of new or newly-enlarging T2 hyperintense lesions reducing the proportion of participants with relapses and improving quality of life
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