A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
This study will compare the effect of A4I antagonist and placebo on MRI lesions,on 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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.|
- Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
- No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS
|Study Start Date:||October 2007|
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|Study Director:||Clinical Trials||Hoffmann-La Roche|