Dimethyl Fumarate

Multiple Sclerosis

Treatment

1 FDA approval

20 Active Studies for Dimethyl Fumarate

What is Dimethyl Fumarate

Dimethyl fumarate

The Generic name of this drug

Treatment Summary

Dimethyl fumarate is an anti-inflammatory medication used to treat multiple sclerosis with relapsing forms. It is also being studied as a possible treatment for psoriasis. The exact way that it works is not yet known, but it is believed to activate a pathway in the body called the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway which is triggered when the body is exposed to oxidative stress. Dimethyl fumarate is known by the brand name Tecfidera.

Tecfidera

is the brand name

image of different drug pills on a surface

Dimethyl Fumarate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tecfidera

Dimethyl fumarate

2013

54

Approved as Treatment by the FDA

Dimethyl fumarate, otherwise called Tecfidera, is approved by the FDA for 1 uses like Multiple Sclerosis .

Multiple Sclerosis

Helps manage Multiple Sclerosis

Effectiveness

How Dimethyl Fumarate Affects Patients

We don't know exactly how dimethyl fumarate affects the body, but it is believed to reduce inflammation and protect cells. It is used to treat multiple sclerosis, but can lead to serious infections, a decrease in white blood cells, liver damage, anaphylaxis, and swelling of the face and throat. While it does not usually cause long-term changes to the heart rate, it is still important to speak with a doctor about any possible side effects.

How Dimethyl Fumarate works in the body

We don't know exactly how dimethyl fumarate works to treat multiple sclerosis, but it appears to reduce inflammation and oxidative stress in the body. It does this by increasing a protein called Nrf2 and decreasing a protein called NF-kappa B, which are both involved in the inflammatory process. Dimethyl fumarate also changes the composition of immune cells, making them less likely to cause inflammation.

When to interrupt dosage

The quantity of Dimethyl Fumarate is contingent upon the diagnosed state. The amount further varies as per the method of delivery (e.g. Capsule, delayed release - Oral or Oral) indicated in the table hereunder.

Condition

Dosage

Administration

Multiple Sclerosis

, 120.0 mg, 240.0 mg, 360.0 mg, 30.0 mg

, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Capsule - Oral, Capsule, Tablet, delayed release - Oral, Tablet, delayed release

Warnings

There are 20 known major drug interactions with Dimethyl Fumarate.

Common Dimethyl Fumarate Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Acteoside

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Antilymphocyte immunoglobulin (horse).

Bacillus calmette-guerin substrain russian BCG-I live antigen

Major

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Dimethyl fumarate.

Baricitinib

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Baricitinib.

Dimethyl Fumarate Toxicity & Overdose Risk

Overdosing on dimethyl fumarate has been reported. There are no specific treatments to remove the drug from the body or counteract the overdose. Symptoms can be managed with supportive care. In animal studies, mice given high doses of dimethyl fumarate had a higher risk of developing tumors in their stomachs and kidneys. At a lower dose, which is equivalent to the recommended human dose, there was no evidence of tumors. Dimethyl fumarate did not cause mutations in bacteria, but did cause chromosomal changes in human cells in laboratory tests.

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Dimethyl Fumarate Novel Uses: Which Conditions Have a Clinical Trial Featuring Dimethyl Fumarate?

Currently, 193 active studies are investigating the potential of Dimethyl Fumarate to provide a therapeutic benefit for Multiple Sclerosis.

Condition

Clinical Trials

Trial Phases

Multiple Sclerosis

116 Actively Recruiting

Phase 3, Not Applicable, Phase 1, Phase 2, Phase 4, Early Phase 1

Dimethyl Fumarate Reviews: What are patients saying about Dimethyl Fumarate?

5

Patient Review

1/12/2015

Dimethyl Fumarate for Multiple Sclerosis Symptoms Return then Become Less Severe

I swapped to Tecfiderea from Rebif and the reduction in my fatigue levels has been dramatic.

4.7

Patient Review

10/8/2013

Dimethyl Fumarate for Multiple Sclerosis Symptoms Return then Become Less Severe

I experienced some stomach upset when I first started taking this medication, but it seems like my body has adjusted to it now.

4.3

Patient Review

2/15/2019

Dimethyl Fumarate for Multiple Sclerosis Symptoms Return then Become Less Severe

I think this is one of the best drugs on the market. You could also try dimegen, which is a generic version of Techfidera that's five times cheaper. Just remember that medicines can only prolong the effects of the disease; you have to take care of your health through diet, too. Avoiding non-vegetarian food is a good place to start.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about dimethyl fumarate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is another name for dimethyl fumarate?

"Dimethyl fumarate is a DMT for relapsing MS that comes in the form of a tablet. Its brand name is Tecfidera."

Answered by AI

What is dimethyl fumarate used for?

"This medicine is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease."

Answered by AI

Is dimethyl fumarate toxic?

"Some potential side effects of multiple sclerosis medication include flushing, gastrointestinal issues such as diarrhea and nausea, and upper abdominal pain. There are also warnings about the possibility of more serious reactions such as anaphylaxis and angioedema, PML, lymphopenia, and liver damage."

Answered by AI

Is dimethyl fumarate FDA approved?

"In March of 2013, the US Food and Drug Administration approved the use of dimethyl fumarate for the first-line treatment of adults with relapsing forms of MS. Dimethyl fumarate is a nuclear factor (erythroid-derived 2) activator, which means it helps to improve the function of cells."

Answered by AI

Clinical Trials for Dimethyl Fumarate

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Functional Balance Intervention for Multiple Sclerosis

40 - 90
All Sexes
Chicago, IL

The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

Recruiting
Has No Placebo

University of Illinois at Chicago

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Mindset Training for MS

18 - 65
All Sexes
Buffalo, NY

People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).

Recruiting
1 Prior Treatment

Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo

Hanneke E Hulst, Prof

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Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY

The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis. Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells. A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy. The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.

Phase 1 & 2
Waitlist Available

Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)

Gavin Solomon, President & CEO

Truway Health, Inc.

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Ocrelizumab for Multiple Sclerosis

18 - 75
All Sexes
Detroit, MI

This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.

Waitlist Available
Has No Placebo

John D. Dingell VA Medical Center

Genentech, Inc.

Image of Toronto Rehabilitation Institute in Toronto, Canada.

Balance Training with Electrical Stimulation for Multiple Sclerosis

18 - 65
All Sexes
Toronto, Canada

This study will evaluate the effects of combining balance training with electrical stimulation techniques in individuals with Multiple Sclerosis (MS). MS commonly impairs leg strength, coordination, and balance, increasing the risk of falls and reducing independence. The interventions include:Balance training only, Balance training with Functional Electrical Stimulation (FES), and Balance training with FES and Transcutaneous Spinal Cord Stimulation (TSCS). FES delivers small electrical pulses to leg muscles, while TSCS delivers electrical signals through the skin to stimulate the spinal cord and enhance motor control. The study will enroll up to 24 participants over a 3-year period. This trial is funded by MS Canada. Participants will be randomly assigned to one of three groups: (1) balance training only, (2) balance training with FES, or (3) balance training with FES and TSCS. All participants will complete 12 supervised training sessions over 6 weeks. During each session, participants will engage in interactive balance games while standing in a safety harness.Outcome assessments will be conducted at three time points: baseline (prior to training), post-intervention (after 6 weeks), and follow-up (8 weeks after training). Assessments will include: * Clinical tests of mobility and balance (Timed Up and Go:TUG, 10-Meter Walk Test:10MWT, Berg Balance Scale:BBS) * Computerized balance testing using a force plate * Questionnaires on walking ability, fear of falling, and balance confidence * Neurophysiological measures of brain-spinal cord-muscle communication before and after training

Waitlist Available
Senior-friendly

Toronto Rehabilitation Institute

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[F-18]FDG-PET for MS

18 - 70
All Sexes
Boston, MA

Given the need for better diagnostic imaging techniques in multiple sclerosis (MS), the study aims to investigate the utility of \[F-18\]FDG positron emission tomography (PET) in MS. The study will be assessing glucose consumption patterns in subjects with progressive MS (PMS) and relapsing-remitting MS (RRMS), as well as healthy controls. PET will be compared to magnetic resonance imaging (MRI) lesion load and brain atrophy, and serum and blood biomarkers, as well as clinical measures of physical disability, cognitive impairment, fatigue, and depression. This study's findings may pave a path for integrating \[F-18\]FDG-PET in routine clinical practice for MS, improving patient experiences and outcomes. The specific aims of the study are: Aim 1: To compare glucose consumption in the brain in subjects with PMS, relapsing-remitting MS (RRMS), and healthy controls, using the radiolabeled glucose analogue 18-fluorodeoxyglucose, also known as \[F-18\]FDG. Aim 2: To compare the relationship between FDG-PET and standard 3T MRI measures including global and regional brain atrophy and lesion load, and to compare FDG-PET with MRI in terms of their relationship with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS subjects. Aim 3: To assess the relationship of FDG-PET with serum and blood biomarkers, including but not limited to sNfL, GFAP, IL-6, and TNFα in MS.

Phase 4
Recruiting

Brigham & Women's Hospital

Tarun Singhal, MD, MBBS

Genzyme, a Sanofi Company

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