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Dose-finding Study of MT-1303

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742052
First Posted: December 5, 2012
Last Update Posted: September 14, 2016
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.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose

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
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

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 ]

Enrollment: 415
Study Start Date: January 2013
Study Completion Date: October 2014
Primary Completion Date: July 2014 (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
Placebo
Drug: Placebo

  Eligibility

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
Criteria

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
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


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

Publications:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01742052     History of Changes
Other Study ID Numbers: MT-1303-E04
First Submitted: December 2, 2012
First Posted: December 5, 2012
Last Update Posted: September 14, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Sclerosis
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