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

NCT07138833 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dimethyl Fumarate Enteric-coated Capsules

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

Sponsors & Collaborators

  • Qilu Pharmaceutical (Hainan) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-04-30
Completion
2028-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07138833 on ClinicalTrials.gov