A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)

StatusNot Yet Recruiting
PhasePhase 4
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07138833
Lead Sponsor Qilu Pharmaceutical (Hainan) Co., Ltd.
Conditions
(from sponsor)
Relapsing Multiple Sclerosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov