Clinical trials: Tecfidera
Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT02428218
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a…
- Trial name
- NCT00837785
- Testing
- BG00012
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Biogen
Intracerebral Hemorrhage
Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
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 alleviating PHE and neurologic…
- Trial name
- NCT04890379
- Testing
- Dimethyl fumarate
- Where
- China
- Sponsor
- Xuanwu Hospital, Beijing
Relapsing-Remitting Multiple Sclerosis
Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)
The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from…
- Trial name
- STRATEGY (NCT02159573)
- Testing
- natalizumab, dimethyl fumarate
- Where
- 43 sites in United States
- Volunteers
- 530 people
- Sponsor
- Biogen
Multiple Sclerosis
Tecfidera and MRI for Brain Energy in MS
The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS.
- Trial name
- NCT02644083
- Testing
- Dimethyl fumarate
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Oregon Health and Science University
Multiple Sclerosis (MS) Relapsing Remitting
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
The investigators propose a multi-center pilot study, which aims to evaluate safety and efficacy of fumarates as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.
- Trial name
- NCT07757568
- Testing
- Vumerity, Tecfidera
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Colorado, Denver
Healthy
BG00012 Regional Absorption Study
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying…
- Trial name
- NCT01924832
- Testing
- dimethyl fumarate
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Multiple Sclerosis
Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients
The purposes of this study is to identify types of bacteria that reside in the intestine of healthy individuals and compare them to individuals with Multiple Sclerosis (MS).
- Trial name
- NCT03092544
- Testing
- dimethyl fumarate
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Multiple Sclerosis Center of Northeastern New York
Healthy
Alternate Dosing Regimens of BG00012 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
- Trial name
- 109HV106 (NCT01281111)
- Testing
- Dimethyl Fumarate (BG00012), Aspirin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region
The purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing routine clinical care for RRMS in MENA…
- Trial name
- NCT04468165
- Testing
- Dimethyl Fumarate (DMF)
- Where
- 6 sites in Algeria, Egypt and 1 more
- Volunteers
- 160 people
- Sponsor
- Hikma Pharmaceuticals LLC
Relapsing Remitting Multiple Sclerosis
Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
This study will observe participants with relapsing remitting multiple sclerosis who are switching therapies from natalizumab to dimethyl fumarate to determine disease stability.
- Trial name
- IIT6 (NCT01945359)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Rocky Mountain MS Research Group, LLC
Type 1 Diabetes Mellitus
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
This is a non-randomized, parallel-controlled, single-center, open-label clinical trial designed to evaluate the efficacy of dimethyl fumarate in preserving pancreatic beta-cell function in adults with type 1 diabetes, as well as…
- Trial name
- NCT07548996
- Testing
- Dimethyl Fumarate Enteric-coated Capsules, Insulin
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Nanjing Medical University
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.
- Trial name
- PROTEC (NCT01930708)
- Testing
- dimethyl fumarate
- Where
- 90 sites in Austria, Belgium and 9 more
- Volunteers
- 1,114 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Tecfidera and the Gut Microbiota
The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota.
- Trial name
- TECONGUT (NCT02471560)
- Testing
- dimethyl fumarate, injectable MS DMT
- Where
- 7 sites in Norway
- Volunteers
- 36 people
- Sponsor
- Biogen
Tecfidera, Teriflunomide
Teriflunomide Tecfidera LMCE
This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)
- Trial name
- NCT03526224
- Testing
- Dimethyl Fumarate, Teriflunomide
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University at Buffalo
Multiple Sclerosis
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl…
- Trial name
- MITIGATE (NCT02410278)
- Testing
- dimethyl fumarate, montelukast
- Where
- 50 sites in United States
- Volunteers
- 102 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT02525874
- Testing
- dimethyl fumarate
- Where
- 34 sites in United States, Belgium and 5 more
- Volunteers
- 218 people
- Sponsor
- Biogen
Plaque Psoriasis
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment
The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.
- Trial name
- NCT02634801
- Testing
- Fumaric Acid Esters, Methotrexate, Ixekizumab
- Where
- 21 sites in Germany
- Volunteers
- 162 people
- Sponsor
- Eli Lilly and Company
Multiple Sclerosis
Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients
The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.
- Trial name
- ADIMS (NCT02099370)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of South Florida
Acute Ischemic Stroke
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in 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 combination with alteplase in…
- Trial name
- NCT04890366
- Testing
- Dimethyl Fumarate
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xuanwu Hospital, Beijing