Status:
COMPLETED
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Teva Neuroscience, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will: * Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol. * Compare whether the decrease in the cumulative number ...
Detailed Description
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS...
Eligibility Criteria
Inclusion
- Patients diagnosed with clinically definite MS according to the McDonald criteria
- Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse
- Age 18-65
- Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of \>9 T2 lesions in addition to 1 Gd lesion)
- Have EDSS scores less than or equal to 5.5
- Have disease duration of 3 months to 30 years
- None of the exclusion criteria
Exclusion
- Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00937157
Start Date
September 1 2007
End Date
April 1 2011
Last Update
March 19 2021
Active Locations (1)
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1
Jacobs Neurological Institute
Buffalo, New York, United States, 14203