This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary progressive mltiple sclerosis (SPMS) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
National Center of Neurology and Psychiatry
Tokyo, Japan
The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline
Time frame: Change from screening at Month 6.
annual relapse rate
Time frame: Month 6
Detection of asymptomatic
Time frame: Month 6
Expanded Disability Status Scale (EDSS) / Functional Scale (FS)
Time frame: screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks
Duration of sustained reduction in disability (SRD)
Time frame: Month 6
Change of MRI
Time frame: Change from screening at Month 3 and 6
Change of No evidence of disease activity (NEDA)
Time frame: Change from screening at Month 3 and 6
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