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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
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE December 2, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date September 14, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2012)
The total number of MRI Gd-enhanced T1-weighted lesions [ Time Frame: Weeks 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-finding Study of MT-1303
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-remitting Multiple Sclerosis
Intervention  ICMJE
  • Drug: MT-1303-Low
  • Drug: MT-1303-Middle
  • Drug: MT-1303-High
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: MT-1303-Low
    MT-1303-Low Dose
    Intervention: Drug: MT-1303-Low
  • Experimental: MT-1303-Middle
    MT-1303-Middle Dose
    Intervention: Drug: MT-1303-Middle
  • Experimental: MT-1303-High
    MT-1303-High Dose
    Intervention: Drug: MT-1303-High
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Kappos L, Arnold DL, Bar-Or A, Camm J, Derfuss T, Kieseier BC, Sprenger T, Greenough K, Ni P, Harada T. Safety and efficacy of amiselimod in relapsing multiple sclerosis (MOMENTUM): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016 Oct;15(11):1148-59. doi: 10.1016/S1474-4422(16)30192-2. Epub 2016 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2014)
415
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2012)
400
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   Croatia,   Czech Republic,   Finland,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Russian Federation,   Serbia,   Spain,   Switzerland,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01742052
Other Study ID Numbers  ICMJE MT-1303-E04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP