Relapsing-remitting Multiple Sclerosis
Conditions
Keywords
relapsing-remitting multiple sclerosis, RRMS
Brief summary
The primary objectives of the study are: * 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.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* RRMS as defined by the revised McDonald 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
* Primary progressive, secondary progressive or progressive relapsing MS at screening * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of MRI Gd-enhanced T1-weighted lesions | Weeks 24 |
Countries
Belgium, Bulgaria, Canada, Croatia, Czechia, Finland, Germany, Hungary, Italy, Lithuania, Poland, Russia, Serbia, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Outcome results
None listed