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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Unnamed facility
Sofia, Bulgaria
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
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Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Edmonton, Alberta, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
London, Ontario, Canada
Unnamed facility
Greenfield Park, Quebec, Canada
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Hull, Quebec, Canada
Unnamed facility
Hradec Králové, Czechia
...and 29 more locations