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Dose-finding Study of MT-1303

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01742052
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : September 14, 2016
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:

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 or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: MT-1303-Low Drug: MT-1303-Middle Drug: MT-1303-High Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The total number of MRI Gd-enhanced T1-weighted lesions [ Time Frame: Weeks 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742052

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Research Site
Brussels, Belgium
Research Site
Sofia, Bulgaria
Research Site
Edmonton, Canada
Research Site
Zagreb, Croatia
Czech Republic
Research Site
Praha, Czech Republic
Research Site
Vantaa, Finland
Research Site
Berlin, Germany
Research Site
Budapest, Hungary
Research Site
Roma, Italy
Research Site
Kaunas, Lithuania
Research Site
Katowice, Poland
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Belgrade, Serbia
Research Site
Madrid, Spain
Research Site
Basel, Switzerland
Research Site
Kozyatagi, Istanbul, Turkey
Research Site
Kiev, Ukraine
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01742052    
Other Study ID Numbers: MT-1303-E04
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
relapsing-remitting multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases