A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)
Status:
NOT_YET_RECRUITING
Trial end date:
2028-08-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate the efficacy and safety\] in \[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).
The main questions it aims to answer are:
\[Question 1\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.
\[Question 2\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.
Participants will:
Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.
The annualized relapse rate (ARR) at Week 48 will be observed.