A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, 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 Tanabe Pharma Corporation (MTPC)0 个研究点目标入组 400 人开始时间: 2012年9月5日最近更新: 2014年12月8日

研究概览

暂无简介。

•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.
•*In Lithuania only: Provided that only patients who have already received treatment with disease modifying medications (IFN-beta and/or glatiramer acetate) that are available and compensated in Lithuania in accordance with the Order No. V-729 of the Minister of Health Care of the Republic in Lithuania dated 1 August 2008 (published in the Official Gazette Valstybes zinios”, 2008, No. 91-3658:2011, No.9-407) are included in the study, but have been discontinued because of lack of efficacy or side effects, or because the patient has refused such treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 415
•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 Tanabe Pharma Corporation (MTPC)