A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002470-31-HU
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-25
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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:
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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified