Extension Study of MT-1303

Mitsubishi Tanabe Pharma logo

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

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

Trial contacts and locations

17

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems