Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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 of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.

• Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.

This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Collaborator: Teva Neuroscience, Inc.
• Treatments: (T,G)-A-L; Glatiramer Acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.)