Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07138833
PHASE4

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

Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09

Completion Date

2028-08

Last Updated

2025-08-24

Healthy Volunteers

No

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