Phase
Condition
Multiple Sclerosis
Scar Tissue
Memory Loss
Treatment
Dimethyl fumarate
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must have a baseline (pre-dose on Day 1) Expanded Disability Status Scale (EDSS)between 0.0 and 5.0, inclusive.
Must have experienced at least 1 documented relapse within the 12 months beforescreening, with a prior brain magnetic resonance imaging (MRI) demonstratinglesion(s) consistent with MS or have showed evidence of GdE lesion(s) of the brainon an MRI performed within the 6 weeks prior to screening.
Exclusion
Key Exclusion Criteria:
An MS relapse that occurred within the 30 days prior to screening and/or theparticipant has not stabilized from a previous relapse prior to screening.
Current hepatitis C infection and current hepatitis B infection. Participants withimmunity to hepatitis B from previous natural infection or vaccination are eligibleto participate in the study.
History of severe allergic or anaphylactic reactions or of any allergic reactionsthat, in the opinion of the Investigator, are likely to be exacerbated by anycomponent 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 traditionaland/or unlicensed medicines and/or traditional therapies and/or herbal preparations,which are known or considered by the Investigator to affect MS and endpoints thatare being considered in the study, including safety and efficacy.
Current enrollment in any other investigational drug study or participation in anyother investigational study within 6 months prior to screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Beijing Hospital
Beijing, 100730
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, 410008
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu City, 610041
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005
ChinaSite Not Available
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
ChinaSite Not Available
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510630
ChinaSite Not Available
The First Affiliated Hospital of Zhejiang University school
Hangzhou, 310003
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Hebei, 050004
ChinaSite Not Available
The First People's Hospital of Yunnan Province
Kunming, 650032
ChinaSite Not Available
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, 210008
ChinaSite Not Available
Huashan Hospital, Fudan University
Shanghai, 200040
ChinaSite Not Available
Renji Hospital, Shanghai Jiatong Uni. School of Medicine
Shanghai, 200001
ChinaSite Not Available
The First Hospital of China Medical University
Shengyang, 110002
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, 215004
ChinaSite Not Available
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, 30001
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 300052
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
ChinaSite Not Available
Second Affiliated Hospital of Air Force Medical University
Xi'An, 710038
ChinaSite Not Available
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