Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tanabe Pharma Corporation
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
