The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Mt. Sinai School of Medicine
New York, New York, United States
Change in number of GAD-enhancing lesions from baseline
Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6
Time frame: 3, 4, 5, and 6 months
Change in number of T2 lesions from baseline
Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment
Time frame: Months 3, 4, 5, and 6
Brain volume
Brain volume by MRI over 6 months of treatment
Time frame: 6 months
T2 lesion volume
T2 lesion volume by MRI over 6 months of treatment
Time frame: 6 month
Annualized Relapse Rate
Annualized Relapse Rate over 6 months
Time frame: 6 months
Expanded Disability Status Scale (EDSS), change from baseline
Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.
Time frame: 3, 6 months
Multiple Sclerosis Functional Composite, change from baseline
Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.
Time frame: 3, 6 months
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