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The primary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1303-Low | Experimental | MT-1303-Low Dose |
|
| MT-1303-Middle | Experimental | MT-1303-Middle Dose |
|
| MT-1303-High | Experimental | MT-1303-High Dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1303-Low | Drug |
| ||
| MT-1303-Middle |
| Measure | Description | Time Frame |
|---|---|---|
| The total number of MRI Gd-enhanced T1-weighted lesions | Weeks 24 |
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Inclusion Criteria:
RRMS as defined by the revised McDonald criteria
Evidence of recent MS activity defined as either:
Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brussels | Belgium | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27543447 | Background | Kappos L, Arnold DL, Bar-Or A, Camm J, Derfuss T, Kieseier BC, Sprenger T, Greenough K, Ni P, Harada T. Safety and efficacy of amiselimod in relapsing multiple sclerosis (MOMENTUM): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016 Oct;15(11):1148-59. doi: 10.1016/S1474-4422(16)30192-2. Epub 2016 Aug 16. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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|
| MT-1303-High | Drug |
|
| Placebo | Drug |
|
| Sofia |
| Bulgaria |
| Research Site | Edmonton | Canada |
| Research Site | Zagreb | Croatia |
| Research Site | Prague | Czechia |
| Research Site | Vantaa | Finland |
| Research Site | Berlin | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Roma | Italy |
| Research Site | Kaunas | Lithuania |
| Research Site | Katowice | Poland |
| Research Site | Moscow | Russia |
| Research Site | Belgrade | Serbia |
| Research Site | Madrid | Spain |
| Research Site | Basel | Switzerland |
| Research Site | Kozyatagi, Istanbul | Turkey (Türkiye) |
| Research Site | Kiev | Ukraine |
| Research Site | London | United Kingdom |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |