Extension Study of MT-1303

Tanabe Pharma Corporation367 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

367

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

MT-1303-LowDRUG

MT-1303-MiddleDRUG

MT-1303-HighDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (17)

Research Site

City Name, Belgium

Research Site

City Name, Bulgaria

Research Site

City Name, Canada

Outcomes

Primary Outcomes

Safety assessments

Adverse Events

Time frame: Month 18

Secondary Outcomes

Clinical efficacy

Annualised relapse rate(ARR)

Time frame: Month 18

Magnetic Resonance Imaging (MRI)

Change and percent change in brain volume at EOT

Time frame: Month 18

Data from ClinicalTrials.gov

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