Relapsing-remitting Multiple Sclerosis
Conditions
Keywords
relapsing-remitting multiple sclerosis, RRMS
Brief summary
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessments | Month 18 | Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy | Month 18 | Annualised relapse rate(ARR) |
| Magnetic Resonance Imaging (MRI) | Month 18 | Change and percent change in brain volume at EOT |
Countries
Belgium, Bulgaria, Canada, Croatia, Czechia, Finland, Germany, Hungary, Italy, Lithuania, Poland, Russia, Serbia, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Outcome results
None listed