Status:
WITHDRAWN
A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00104143
Start Date
October 1 2007
Last Update
August 24 2016
Active Locations (39)
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1
Sofia, Bulgaria, 1113
2
Sofia, Bulgaria, 1309
3
Sofia, Bulgaria, 1527
4
Sofia, Bulgaria, 1606