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Dimethyl fumarate

Generic Name
Dimethyl fumarate
Brand Names
Tecfidera, Skilarence, Dimethyl fumarate Neuraxpharm, Dimethyl fumarate Mylan, Dimethyl fumarate Accord
Drug Type
Small Molecule
Chemical Formula
C6H8O4
CAS Number
624-49-7
Unique Ingredient Identifier
FO2303MNI2
Background

Dimethyl fumarate is an agent indicated for the treatment of relapsing forms of multiple sclerosis. The mechanism of action of dimethyl fumarate in multiple sclerosis is not well understood. It is thought to involve dimethyl fumarate degradation to its active metabolite monomethyl fumarate (MMF) then MMF up-regulates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway that is activated in response to oxidative stress. Dimethyl fumarate is marketed under the brand name Tecfidera, and it was the third oral disease-modifying agent for multiple sclerosis approved by the FDA, following fingolimod and teriflunomide. Prior to its FDA approval, dimethyl fumarate had been used in Germany for treatment of psoriasis.

Indication

Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Associated Conditions
Clinically Isolated Syndrome (CIS), Relapsing Forms of MS, Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Tecfidera Diffusion Tensor Imaging

Completed
Conditions
Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging
Interventions
First Posted Date
2016-02-19
Last Posted Date
2016-10-26
Lead Sponsor
University at Buffalo
Target Recruit Count
115
Registration Number
NCT02686684

Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS

Phase 4
Withdrawn
Conditions
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Interventions
First Posted Date
2016-02-05
Last Posted Date
2016-07-20
Lead Sponsor
Washington University School of Medicine
Registration Number
NCT02675413
Locations
🇺🇸

Swedish Neuroscience Institute, Seattle, Washington, United States

🇺🇸

Washington University (John L. Trotter MS Center), St. Louis, Missouri, United States

Tecfidera and MRI for Brain Energy in MS

Terminated
Conditions
Multiple Sclerosis
First Posted Date
2015-12-31
Last Posted Date
2018-08-29
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
4
Registration Number
NCT02644083
Locations
🇺🇸

Oregon Health & Science University, Portland, Oregon, United States

Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012

Phase 3
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2015-10-20
Last Posted Date
2017-04-27
Lead Sponsor
Biogen
Target Recruit Count
221
Registration Number
NCT02579681
Locations
🇮🇹

Research site, Roma, Italy

Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Phase 3
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2015-09-21
Last Posted Date
2019-11-22
Lead Sponsor
Biogen
Target Recruit Count
20
Registration Number
NCT02555215
Locations
🇹🇷

Research Site, Ankara, Turkey

Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)

Phase 2
Completed
Conditions
Cutaneous T Cell Lymphoma
Interventions
First Posted Date
2015-09-10
Last Posted Date
2023-03-31
Lead Sponsor
Universitätsmedizin Mannheim
Target Recruit Count
25
Registration Number
NCT02546440
Locations
🇩🇪

University Medical Center, Mannheim, Germany

Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

Phase 3
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Interventions
First Posted Date
2015-08-18
Last Posted Date
2019-06-27
Lead Sponsor
Biogen
Target Recruit Count
218
Registration Number
NCT02525874
Locations
🇹🇷

Research Site, Umuttepe, Kocaeli, Turkey

Tecfidera Lymphocyte Chart Review

Completed
Conditions
Multiple Sclerosis
First Posted Date
2015-08-10
Last Posted Date
2016-08-26
Lead Sponsor
Biogen
Target Recruit Count
483
Registration Number
NCT02519413
Locations
🇺🇸

Research site, Homewood, Alabama, United States

🇺🇸

Research Site, Milwaukee, Wisconsin, United States

Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

Phase 4
Withdrawn
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2015-06-16
Last Posted Date
2015-12-28
Lead Sponsor
Biogen
Registration Number
NCT02472938

Tecfidera and the Gut Microbiota

Phase 4
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
Drug: injectable MS DMT
First Posted Date
2015-06-15
Last Posted Date
2021-09-05
Lead Sponsor
Biogen
Target Recruit Count
36
Registration Number
NCT02471560
Locations
🇳🇴

Research site, Stavanger, Norway

🇳🇴

Research Site, Lillehammer, Norway

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