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Extension 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
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:

  • Completion of the 24-week treatment period in MT-1303-E04 as per protocol
  • Able to provide written informed consent and to comply with the requirements of the protocol
  • For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.

Exclusion Criteria:

  • Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
  • Newly diagnosed diabetes mellitus during MT-1303-E04

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MT-1303-Low

MT-1303-Middle

MT-1303-High

Arm Description

MT-1303-Low Dose

MT-1303-Middle Dose

MT-1303-High Dose

Outcomes

Primary Outcome Measures

Safety assessments
Adverse Events

Secondary Outcome Measures

Clinical efficacy
Annualised relapse rate(ARR)
Magnetic Resonance Imaging (MRI)
Change and percent change in brain volume at EOT

Full Information

First Posted
June 26, 2013
Last Updated
April 8, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01890655
Brief Title
Extension Study of MT-1303
Official Title
A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (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
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (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
367 (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
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
Primary Outcome Measure Information:
Title
Safety assessments
Description
Adverse Events
Time Frame
Month 18
Secondary Outcome Measure Information:
Title
Clinical efficacy
Description
Annualised relapse rate(ARR)
Time Frame
Month 18
Title
Magnetic Resonance Imaging (MRI)
Description
Change and percent change in brain volume at EOT
Time Frame
Month 18

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: Completion of the 24-week treatment period in MT-1303-E04 as per protocol Able to provide written informed consent and to comply with the requirements of the protocol For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method. Exclusion Criteria: Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04 Newly diagnosed diabetes mellitus during MT-1303-E04
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludwig Kappos, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
City name
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Belgium
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Finland
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Germany
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Hungary
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Italy
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Lithuania
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Poland
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Russian Federation
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Serbia
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Spain
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Turkey
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Ukraine
Facility Name
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City
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United Kingdom

12. IPD Sharing Statement

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Extension Study of MT-1303

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