A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
NCT ID: NCT05658484
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2023-06-09
2025-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dimethyl fumarate (DMF)
Participants will receive DMF 120 mg capsules, orally, twice daily (BID) for the first 7 days, followed by 240 mg BID (maintenance dose) after 7 days for up to Week 48.
Dimethyl fumarate
Administered as specified in the treatment arm.
Interventions
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Dimethyl fumarate
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have experienced at least 1 documented relapse within the 12 months before screening, with a prior brain magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS or have showed evidence of GdE lesion(s) of the brain on an MRI performed within the 6 weeks prior to screening.
Exclusion Criteria
* Current hepatitis C infection and current hepatitis B infection. Participants with immunity to hepatitis B from previous natural infection or vaccination are eligible to participate in the study.
* History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the Investigator, are likely to be exacerbated by any component of the study treatment.
* History or positive test result at screening for human immunodeficiency virus (HIV).
* Use at the time of enrollment and/or anticipated ongoing use of any traditional and/or unlicensed medicines and/or traditional therapies and/or herbal preparations, which are known or considered by the Investigator to affect MS and endpoints that are being considered in the study, including safety and efficacy.
* Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to screening.
18 Years
65 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Beijing Hospital
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, , China
The Second Hospital of Hebei Medical University
Hebei, , China
The First People's Hospital of Yunnan Province
Kunming, , China
Renji Hospital, Shanghai Jiatong Uni. School of Medicine
Shanghai, , China
Huashan Hospital, Fudan University
Shanghai, , China
The First Hospital of China Medical University
Shengyang, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Second Affiliated Hospital of Air Force Medical University
Xi'an, , China
Countries
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Other Identifiers
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109MS424
Identifier Type: -
Identifier Source: org_study_id
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