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

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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

138 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

Image of MS Barlo Centre, St Michael's Hospital in Toronto, Canada.

Online Cognitive Behavioural Therapy for Depression

18+
All Sexes
Toronto, Canada

Individuals with MS experience significantly high levels of depression which are higher than in any other chronic illness or neurological disorder. Depression can occur at any point in the course of the disease. Cognitive behavioural therapy (CBT) has been found to be effective in treating depression in people with MS. However, many individuals with MS who would benefit from CBT for depression do not participate in face-to-face treatment due to lack of clinician referral, accessibility, modality preference, cost, and mobility and travel issues due to health reasons. Given the acceptability and preference for telehealth treatment options, digital-based psychological interventions can be another appealing treatment option as these programs have the ability to deliver interactive CBT treatments for depression to individuals with MS at a time and location convenient to the individual. The current trial proposes to test the acceptability, effectiveness, satisfaction and cost-effectiveness of an 8-week online depression intervention targeting individuals with multiple sclerosis and compare this intervention with an 8-week online health and wellbeing in MS informational intervention.

Waitlist Available
Has No Placebo

MS Barlo Centre, St Michael's Hospital

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Physical Activity Intervention for Multiple Sclerosis

18+
All Sexes
Chicago, IL

The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap. Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group. Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.

Waitlist Available
Has No Placebo

University of Illinois Chicago

Robert Motl, PhD

Image of University of California San Francisco, Weill Institute for Neurosciences in San Francisco, United States.

Functional Electrical Stimulation for Multiple Sclerosis

22 - 75
All Sexes
San Francisco, CA

Multiple sclerosis (MS) is a chronic, neurodegenerative disease and the most common cause of non- traumatic disability in young adults. Foot drop, arising from MS-induced muscle weakness, leads to impaired mobility, increased fall risk, reduced overall physical activity and reduced health-related quality of life. Functional electrical stimulation (FES) represents a revolutionary approach for addressing gait mobility challenges in MS and evolution in the technology has greatly improved its design, comfort, and functionality. Despite its proven benefits, FES is underutilized in MS clinical practice and lacks a comprehensive assessment of its long-term effectiveness and impact in real-world applications. Study objectives are to evaluate the utility of FES for improving function and real-world outcomes in people with MS (PwMS) who have gait impairments. Study design: 4-month randomized controlled trial (RCT) (n=70 PwMS) evaluating FES efficacy. Group 1: 4M FES; Group 2: 4M sham stimulation, followed by both groups: 4M FES, then 1M (no-FES) follow-up assessing carryover. We will assess gait quality, muscle function, physical activity, and FES adoption factors, with covariates including age, sex, MS severity, MS symptoms, biomechanical factors, and device usage patterns.

Waitlist Available
Online Trial

University of California San Francisco, Weill Institute for Neurosciences

Valerie Block, DPTSc

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Spinal Cord Stimulation for Multiple Sclerosis

18 - 70
All Sexes
Seattle, WA

This is a pilot study designed to test the feasibility of in-home, non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with exercises for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete 8-weeks of hand/arm exercises combined with spinal cord stimulation performed at home with the help of a partner. The investigators hypothesize that: 1. in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will be feasible and acceptable by participants 2. in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will lead to improvements in upper extremity function after 8-weeks 3. in-home transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms)

Waitlist Available
Has No Placebo

University of Washington

Sarah Simmons, MD, PhD

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Dry Needling for Multiple Sclerosis

18 - 80
All Sexes
Tampa, FL

This study is placed at the Human Functional Performance Laboratory in the School of physical therapy and Rehabilitation Sciences (MDT building) at University of South Florida. The study is supported by Consortium of Multiple Sclerosis Centers. We are doing this study to see if a treatment called dry needling improves chronic pain in the lower limb (from the low back to the foot) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those used in acupuncture, to target certain muscles, such as the thigh or calf muscles. It is different from traditional acupuncture because it focuses on treating specific muscle spots to reduce muscle stiffness and pain. Dry needling may help reduce your pain without any medication. We also hope to see whether dry needling helps improve balance and walking abilities, which may lead to better day-to-day functioning. In this study, there are two groups. In each group, participants will receive six sessions of dry needling. One group will receive actual dry needling, while the other group will receive a procedure that mimics dry needling. The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given either treatment or sham treatment. You will not be told which treatment you are getting; however your study doctor will know. You are being asked to take part because you have been diagnosed with Multiple Sclerosis and are experiencing long-lasting pain in your lower limbs, including the buttocks, thighs, calf, and foot. We want to find out if this treatment will help people with Multiple Sclerosis who have lower limb pain.

Recruiting
Senior-friendly

University of South Florida

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Silodosin for Urinary Symptoms in Multiple Sclerosis

18+
Female
Morristown, NJ

The goal of this clinical trial is to learn if silodosin works to treat lower urinary tract symptoms (LUTS) in female patients with multiple sclerosis (MS). It will also learn about the effect of the drug on voiding parameters. The main questions it aims to answer are: Does silodosin improve lower urinary tract symptoms based on questionnaires? Does silodosin change Uroflowmetry parameters in female patients with MS? Researchers will compare silodosin to a placebo (a look-alike substance that contains no drug) to see if silodosin works to treat LUTS in female patients with MS. Participants will: Take silodosin or a placebo every day for 8 weeks Visit the clinic before initiating the medication and after 8 weeks of taking the medication for questionnaires and tests

Phase 4
Recruiting

Atlantic Health

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