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Trial record 1 of 1 for:    MT-1303-E05
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Extension Study of MT-1303

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ClinicalTrials.gov Identifier: NCT01890655
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : April 11, 2016
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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

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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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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Research Site
City name, Belgium
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City name, Bulgaria
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City name, Canada
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City name, Croatia
Czech Republic
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City name, Czech Republic
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City name, Finland
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City name, Germany
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City name, Hungary
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City name, Italy
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City name, Lithuania
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City name, Poland
Russian Federation
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City name, Russian Federation
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City name, Serbia
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City name, Spain
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City name, Turkey
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City name, Ukraine
United Kingdom
Research Site
City name, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Study Director: Ludwig Kappos, MD University Hospital, Basel, Switzerland
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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
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases