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Dose-finding Study of MT-1303

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MT-1303-Low
MT-1303-Middle
MT-1303-High
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring relapsing-remitting multiple sclerosis, RRMS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
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  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

MT-1303-Low

MT-1303-Middle

MT-1303-High

Placebo

Arm Description

MT-1303-Low Dose

MT-1303-Middle Dose

MT-1303-High Dose

Placebo

Outcomes

Primary Outcome Measures

The total number of MRI Gd-enhanced T1-weighted lesions

Secondary Outcome Measures

Full Information

First Posted
December 2, 2012
Last Updated
September 12, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01742052
Brief Title
Dose-finding Study of MT-1303
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
relapsing-remitting multiple sclerosis, RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-1303-Low
Arm Type
Experimental
Arm Description
MT-1303-Low Dose
Arm Title
MT-1303-Middle
Arm Type
Experimental
Arm Description
MT-1303-Middle Dose
Arm Title
MT-1303-High
Arm Type
Experimental
Arm Description
MT-1303-High Dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MT-1303-Low
Intervention Type
Drug
Intervention Name(s)
MT-1303-Middle
Intervention Type
Drug
Intervention Name(s)
MT-1303-High
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The total number of MRI Gd-enhanced T1-weighted lesions
Time Frame
Weeks 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Edmonton
Country
Canada
Facility Name
Research Site
City
Zagreb
Country
Croatia
Facility Name
Research Site
City
Praha
Country
Czech Republic
Facility Name
Research Site
City
Vantaa
Country
Finland
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Kaunas
Country
Lithuania
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Kozyatagi, Istanbul
Country
Turkey
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27543447
Citation
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.
Results Reference
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Dose-finding Study of MT-1303

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