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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR DIMETHYL FUMARATE


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All Clinical Trials for Dimethyl Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00420212 ↗ Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis Completed Biogen Phase 3 2007-01-01 To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse. The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
NCT00451451 ↗ Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis Completed Biogen Phase 3 2007-06-01 To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
NCT00835770 ↗ BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) Completed Biogen Phase 3 2009-02-03 The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
NCT01156311 ↗ BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis Completed Biogen Phase 2 2010-06-01 The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
NCT01568112 ↗ Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate Completed Biogen Phase 3 2012-04-01 The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.
NCT01815723 ↗ Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis Withdrawn Forward-Pharma GmbH Phase 3 2016-06-01 This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.
NCT01838668 ↗ An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Completed Biogen Phase 3 2013-03-28 This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region. The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline. The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dimethyl Fumarate

Condition Name

Condition Name for Dimethyl Fumarate
Intervention Trials
Multiple Sclerosis 21
Relapsing-Remitting Multiple Sclerosis 13
Multiple Sclerosis, Relapsing-Remitting 11
Relapsing Remitting Multiple Sclerosis 6
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Condition MeSH

Condition MeSH for Dimethyl Fumarate
Intervention Trials
Multiple Sclerosis 51
Sclerosis 43
Multiple Sclerosis, Relapsing-Remitting 29
Psoriasis 3
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Clinical Trial Locations for Dimethyl Fumarate

Trials by Country

Trials by Country for Dimethyl Fumarate
Location Trials
United States 385
France 42
Canada 34
Germany 30
United Kingdom 28
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Trials by US State

Trials by US State for Dimethyl Fumarate
Location Trials
California 18
Texas 17
Florida 17
North Carolina 16
New York 16
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Clinical Trial Progress for Dimethyl Fumarate

Clinical Trial Phase

Clinical Trial Phase for Dimethyl Fumarate
Clinical Trial Phase Trials
Phase 4 19
Phase 3 17
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Dimethyl Fumarate
Clinical Trial Phase Trials
Completed 36
Terminated 12
Withdrawn 7
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Clinical Trial Sponsors for Dimethyl Fumarate

Sponsor Name

Sponsor Name for Dimethyl Fumarate
Sponsor Trials
Biogen 46
Xuanwu Hospital, Beijing 4
Multiple Sclerosis Center of Northeastern New York 2
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Sponsor Type

Sponsor Type for Dimethyl Fumarate
Sponsor Trials
Industry 56
Other 41
NIH 1
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