Extension Study of MT-1303

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: MT-1303-Low; Drug: MT-1303-High; Drug: MT-1303-Middle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01890655

MT-1303-E05

Details and patient eligibility

About

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

Enrollment: 367 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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367 participants in 3 patient groups

MT-1303-Low

Experimental group

Description:

MT-1303-Low Dose

Treatment:

Drug: MT-1303-Low

MT-1303-Middle

Experimental group

Description:

MT-1303-Middle Dose

Treatment:

Drug: MT-1303-Middle

MT-1303-High

Experimental group

Description:

MT-1303-High Dose

Treatment:

Drug: MT-1303-High