Clinical trials: Tecfidera
Adult Brain Glioblastoma, Adult Giant Cell Glioblastoma
Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given together with temozolomide and radiation therapy(RT) in treating patients with newly diagnosed glioblastoma multiforme (GBM).
- Conditions
- Adult Brain Glioblastoma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma
- Trial name
- NCT02337426
- Testing
- Dimethyl Fumarate, Temozolomide, Radiation Therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Virginia Commonwealth University
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
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…
- Trial name
- NCT01838668
- Testing
- dimethyl fumarate
- Where
- 54 sites in Czechia, Japan and 3 more
- Volunteers
- 225 people
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Single site, open label, randomized design in patients with relapsing forms of Multiple Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS scale to be completed once a day for the first two…
- Trial name
- IIT9 (NCT02217982)
- Testing
- Simethicone, Loperamide, Peanut Butter
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Rocky Mountain MS Research Group, LLC
Multiple Sclerosis
Improving the Effect of Multiple Sclerosis Drugs by Chronobiology
A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a…
- Trial name
- NCT06385197
- Testing
- App randomizing dosing regimen
- Where
- Israel
- Volunteers
- 8 people
- Sponsor
- Hadassah Medical Organization
Acute Ischemic Stroke
Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke
The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in in alleviating neurologic…
- Trial name
- NCT04890353
- Testing
- Dimethyl fumarate
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Xuanwu Hospital, Beijing
Relapsing-Remitting Multiple Sclerosis
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
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…
- Trial name
- CONFIRM (NCT00451451)
- Testing
- BG00012, Glatiramer Acetate
- Where
- 195 sites in United States, Belarus and 26 more
- Volunteers
- 1,417 people
- Sponsor
- Biogen
Relapsing Forms of Multiple Sclerosis
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal…
- Trial name
- RESPOND (NCT01903291)
- Testing
- dimethyl fumarate
- Where
- 62 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biogen
Rheumatoid Arthritis
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA.
- Trial name
- NCT00810836
- Testing
- BG00012
- Where
- 24 sites in Australia, Canada and 4 more
- Volunteers
- 153 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their…
- Trial name
- IMPROVE (NCT02323269)
- Testing
- dimethyl fumarate
- Where
- 10 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate
The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor…
- Trial name
- TECNERGY (NCT02090348)
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting…
- Trial name
- PROMPT (NCT02472938)
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy Volunteers
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01420458
- Testing
- Experimental
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Intracranial Aneurysm, Aneurysm, Brain
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.
- Conditions
- Intracranial Aneurysm, Aneurysm, Brain, Inflammation Vascular
- Trial name
- NCT05959759
- Testing
- Dimethyl fumarate
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Tiantan Hospital
Multiple Sclerosis, Covid19
Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis
This observational study is intended to evaluate the effect of disease modifying therapies on antibody responses to the mRNA-1273 vaccine (Moderna) for COVID-19.
- Trial name
- NCT04834401
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- St. Barnabas Medical Center
Age-related Macular Degeneration (AMD)
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
The primary objectives of the study are to assess the safety, tolerability and evidence of activity of 12 months oral treatment with TEFIDERA® in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration…
- Trial name
- LADIGAGA (NCT04292080)
- Testing
- Dimethyl Fumarate (TECFIDERA™), No active : no treatment
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Multiple Sclerosis
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering…
- Trial name
- RESOunD (NCT02117050)
- Testing
- Rebif®
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- EMD Serono
Healthy
A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
The primary objective of this study is to establish the bioequivalence of the test product (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of…
- Trial name
- NCT02171208
- Testing
- dimethyl fumarate - Reference form, dimethyl fumarate - Test form
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Multiple Sclerosis
Impact of Tecfidera on Gut Microbiota
Objectives: Dimethyl fumarate (DMF) therapy may cause a measureable change in bacterial species of the gut. The primary objectives of this study are: 1.
- Trial name
- NCT02736279
- Testing
- Dimethyl fumarate
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Virginia Simnad
Relapsing Remitting Multiple Sclerosis
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability…
- Trial name
- NCT03093324
- Testing
- ALKS 8700, Dimethyl Fumarate
- Where
- 67 sites in United States, Germany and 1 more
- Volunteers
- 506 people
- Sponsor
- Biogen