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Trial record 1 of 2 for:    MT-1303-E04
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Extension 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: NCT01890655
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: MT-1303-Low Drug: MT-1303-Middle Drug: MT-1303-High Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety assessments [ Time Frame: Month 18 ]
    Adverse Events


Secondary Outcome Measures :
  1. Clinical efficacy [ Time Frame: Month 18 ]
    Annualised relapse rate(ARR)

  2. Magnetic Resonance Imaging (MRI) [ Time Frame: Month 18 ]
    Change and percent change in brain volume at EOT


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT01890655


Locations
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Belgium
Research Site
City name, Belgium
Bulgaria
Research Site
City name, Bulgaria
Canada
Research Site
City name, Canada
Croatia
Research Site
City name, Croatia
Czech Republic
Research Site
City name, Czech Republic
Finland
Research Site
City name, Finland
Germany
Research Site
City name, Germany
Hungary
Research Site
City name, Hungary
Italy
Research Site
City name, Italy
Lithuania
Research Site
City name, Lithuania
Poland
Research Site
City name, Poland
Russian Federation
Research Site
City name, Russian Federation
Serbia
Research Site
City name, Serbia
Spain
Research Site
City name, Spain
Turkey
Research Site
City name, Turkey
Ukraine
Research Site
City name, Ukraine
United Kingdom
Research Site
City name, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: Ludwig Kappos, MD University Hospital, Basel, Switzerland
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01890655    
Other Study ID Numbers: MT-1303-E05
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
relapsing-remitting multiple sclerosis
RRMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases