A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
Phase 2
Withdrawn
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT00104143
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- adult patients, 18-59 years of age;
- relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria);
- >=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment;
- EDSS score of <=6.5;
- inadequate response to approved treatment(Canada only).
Exclusion Criteria
- MS attack within 1 month before enrollment;
- systemic corticosteroids within 1 month before enrollment;
- MS treatments (non-symptomatic) within specified periods before enrollment;
- an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
- Secondary Outcome Measures
Name Time Method 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