Dose-finding Study of MT-1303

This study is currently recruiting participants.
Verified March 2014 by Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: December 2, 2012
Last updated: March 11, 2014
Last verified: March 2014

The primary objectives of the study are:

  • To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
  • To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.

Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
Drug: MT-1303-Low
Drug: MT-1303-Middle
Drug: MT-1303-High
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • The total number of MRI Gd-enhanced T1-weighted lesions [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-1303-Low
MT-1303-Low Dose
Drug: MT-1303-Low
Experimental: MT-1303-Middle
MT-1303-Middle Dose
Drug: MT-1303-Middle
Experimental: MT-1303-High
MT-1303-High Dose
Drug: MT-1303-High
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01742052

Contact: Clinical Trials Information Desk

  Show 18 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT01742052     History of Changes
Other Study ID Numbers: MT-1303-E04
Study First Received: December 2, 2012
Last Updated: March 11, 2014
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
relapsing-remitting multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes processed this record on April 17, 2014