A phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis

MITSUBISHI PHARMA CORPORATIO0 个研究点目标入组 400 人开始时间: 2012年12月13日最近更新: 2015年7月10日

试验速览

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•1. RRMS as defined by the revised McDonald criteria 2. 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 3. Expanded Disability Status Score (EDSS) score =0.0 and =5.5 points.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Primary progressive, secondary progressive or progressive relapsing MS at screening 2. Disease duration >15 years combined with an EDSS score =2.0 3. Relapse of MS during the Screening Period 4. History or known presence of other neurological disorders likely to render the subject unsuitable for the study 5. History of any of a list of pre-defined cardiovascular diseases 6. 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 7. Previous exposure to any sphingosine 1-phosphate receptor modulator 8. Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation 9. Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation 10. Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation 11. 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 12. Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment 13. Clinically significant electrocardiogram (ECG) findings.

发起方

MITSUBISHI PHARMA CORPORATIO