N/A N=12 Diagnostic

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

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00937157 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. — -3.7; -3.6 GAD lesions (number of)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Copaxone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University at Buffalo
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.	-3.7; -3.6	—

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.

Eligibility 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.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00937157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.