Dose-finding Study of MT-1303

Launched by MITSUBISHI TANABE PHARMA CORPORATION · Dec 2, 2012

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.