Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104143
Status:
WITHDRAWN
Last Update Posted:
2016-08-24
First Post:
2005-02-23
Brief Title:
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis
Status:
WITHDRAWN
Status Verified Date:
2016-08
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 compare the effect of A4I antagonist and placebo on MRI lesionson clinical endpoints and safety in patients with relapsing Multiple Sclerosis MS Eligible patients will be randomized to receive placebo or A4I antagonist 20mg 80mg or 300mg po bid Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
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