Status:
COMPLETED
Extension Study of MT-1303
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT01890655
Start Date
August 1 2013
End Date
March 1 2016
Last Update
April 11 2016
Active Locations (17)
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1
Research Site
City Name, Belgium
2
Research Site
City Name, Bulgaria
3
Research Site
City Name, Canada
4
Research Site
City Name, Croatia