Extension Study of MT-1303

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

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