Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
415 participants
INTERVENTIONAL
2013-01-31
2014-10-31
Brief Summary
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* To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
* To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-1303-Low
MT-1303-Low Dose
MT-1303-Low
MT-1303-Middle
MT-1303-Middle Dose
MT-1303-Middle
MT-1303-High
MT-1303-High Dose
MT-1303-High
Placebo
Placebo
Placebo
Interventions
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MT-1303-Low
MT-1303-Middle
MT-1303-High
Placebo
Eligibility Criteria
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Inclusion Criteria
* Evidence of recent MS activity defined as either:
* at least one documented relapse in the previous 12 months, OR
* a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR
* at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months
* Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
Exclusion Criteria
* Disease duration \>15 years combined with an EDSS score ≤2.0
* Relapse of MS during the Screening Period
* History or known presence of other neurological disorders likely to render the subject unsuitable for the study
* History of any of a list of pre-defined cardiovascular diseases
* History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study
* Previous exposure to any sphingosine 1-phosphate receptor modulator
* Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation
* Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation
* Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation
* Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
* Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment
* Clinically significant electrocardiogram (ECG) findings.
18 Years
60 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Locations
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Research Site
Brussels, , Belgium
Research Site
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
Countries
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References
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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.
Other Identifiers
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MT-1303-E04
Identifier Type: -
Identifier Source: org_study_id
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