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OpenTrials
Completed

NCT Number: NCT01890655

Extension Study of MT-1303

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

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, City Name, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-1303-Low

Drug

MT-1303-Middle

Drug

MT-1303-High

Drug

Primary outcomes

  1. Safety assessments

    Time frame: Month 18

    Adverse Events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2013
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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