Extension Study of MT-1303

NCT ID: NCT01890655

Last Updated: 2016-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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Conditions

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Relapsing-remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MT-1303-Low

MT-1303-Low Dose

Group Type EXPERIMENTAL

MT-1303-Low

Intervention Type DRUG

MT-1303-Middle

MT-1303-Middle Dose

Group Type EXPERIMENTAL

MT-1303-Middle

Intervention Type DRUG

MT-1303-High

MT-1303-High Dose

Group Type EXPERIMENTAL

MT-1303-High

Intervention Type DRUG

Interventions

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MT-1303-Low

Intervention Type DRUG

MT-1303-Middle

Intervention Type DRUG

MT-1303-High

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ludwig Kappos, MD

Role: STUDY_DIRECTOR

University Hospital, Basel, Switzerland

Locations

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Research Site

City Name, , Belgium

Site Status

Research Site

City Name, , Bulgaria

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City Name, , Canada

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City Name, , Croatia

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City Name, , Czechia

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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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Research Site

City Name, , Lithuania

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Research Site

City Name, , Poland

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City Name, , Russia

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City Name, , Serbia

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City Name, , Spain

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Research Site

City Name, , Turkey (Türkiye)

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Research Site

City Name, , Ukraine

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Research Site

City Name, , United Kingdom

Site Status

Countries

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Belgium Bulgaria Canada Croatia Czechia Finland Germany Hungary Italy Lithuania Poland Russia Serbia Spain Turkey (Türkiye) Ukraine United Kingdom

Other Identifiers

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MT-1303-E05

Identifier Type: -

Identifier Source: org_study_id

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