Extension Study of MT-1303

April 8, 2016 updated by: Mitsubishi Tanabe Pharma Corporation

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

To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • City name, Belgium
        • Research Site
  • Bulgaria
      • City name, Bulgaria
        • Research Site
  • Canada
      • City name, Canada
        • Research Site
  • Croatia
      • City name, Croatia
        • Research Site
  • Czech Republic
      • City name, Czech Republic
        • Research Site
  • Finland
      • City name, Finland
        • Research Site
  • Germany
      • City name, Germany
        • Research Site
  • Hungary
      • City name, Hungary
        • Research Site
  • Italy
      • City name, Italy
        • Research Site
  • Lithuania
      • City name, Lithuania
        • Research Site
  • Poland
      • City name, Poland
        • Research Site
  • Russian Federation
      • City name, Russian Federation
        • Research Site
  • Serbia
      • City name, Serbia
        • Research Site
  • Spain
      • City name, Spain
        • Research Site
  • Turkey
      • City name, Turkey
        • Research Site
  • Ukraine
      • City name, Ukraine
        • Research Site
  • United Kingdom
      • City name, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessments
Time Frame: Month 18
Adverse Events
Month 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy
Time Frame: Month 18
Annualised relapse rate(ARR)
Month 18
Magnetic Resonance Imaging (MRI)
Time Frame: Month 18
Change and percent change in brain volume at EOT
Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Director: Ludwig Kappos, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (ESTIMATE)

July 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-E05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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