Clinical trials: Tecfidera
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
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 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
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
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
Multiple Sclerosis, Relapsing-Remitting
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- FOCUS (NCT02410200)
- Testing
- dimethyl fumarate
- Where
- 12 sites in United States, Belgium and 8 more
- Volunteers
- 22 people
- Sponsor
- Biogen
Multiple Sclerosis
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
- Trial name
- POINT (NCT02907177)
- Testing
- Ponesimod
- Where
- 119 sites in United States, Australia and 18 more
- Volunteers
- 136 people
- Sponsor
- Actelion
Psoriasis
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type…
- Trial name
- POLARIS (NCT02951533)
- Testing
- Guselkumab, Fumaric Acid Esters
- Where
- 28 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Janssen-Cilag G.m.b.H
Psoriasis
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and…
- Trial name
- NCT03255382
- Testing
- Fumaderm, risankizumab
- Where
- 23 sites in Germany
- Volunteers
- 120 people
- Sponsor
- AbbVie
Psoriasis
Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are…
- Trial name
- PRIME (NCT02474082)
- Testing
- Secukinumab, Fumaric acid
- Where
- 32 sites in Germany
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing-Remitting Multiple Sclerosis
Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012…
- Trial name
- TOLERATE (NCT02125604)
- Testing
- dimethyl fumarate
- Where
- 19 sites in Germany
- Volunteers
- 214 people
- Sponsor
- Biogen
Relapsing Forms of Multiple Sclerosis
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with…
- Trial name
- MANAGE (NCT01873417)
- Testing
- BG00012 (DMF)
- Where
- 37 sites in United States
- Volunteers
- 237 people
- Sponsor
- Biogen
Multiple Sclerosis
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3)…
- Trial name
- NCT02343159
- Testing
- dimethyl fumarate, Medication Event Monitoring System (MEMS), Adherence counseling
- Where
- 29 sites in United States
- Volunteers
- 84 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
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…
- Trial name
- ENDORSE (NCT00835770)
- Testing
- dimethyl fumarate
- Where
- 246 sites in United States, Australia and 32 more
- Volunteers
- 1,736 people
- Sponsor
- Biogen
Multiple Sclerosis (MS)
Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
The purpose of this investigation is to systematically study the efficacy of Tecfidera in those individuals who possess incidental white matter anomalies within the brain following a MRI study that is performed for a reason other…
- Trial name
- ARISE (NCT02739542)
- Testing
- Tecfidera
- Where
- 11 sites in United States
- Volunteers
- 87 people
- Sponsor
- University of Texas Southwestern Medical Center
Relapsing-Remitting Multiple Sclerosis
Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and…
- Trial name
- CONNECT (NCT02283853)
- Testing
- dimethyl fumarate, Interferon β-1a
- Where
- 62 sites in United States, Belgium and 16 more
- Volunteers
- 156 people
- Sponsor
- Biogen
Relapsing Forms of Multiple Sclerosis
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012)…
- Trial name
- NCT02097849
- Testing
- dimethyl fumarate, tetanus diphtheria toxoids vaccine, 23-valent pneumococcal polysaccharide vaccine
- Where
- 14 sites in United States
- Volunteers
- 71 people
- Sponsor
- Biogen
Obstructive Sleep Apnea, OSA
Dimethyl Fumarate for Obstructive Sleep Apnea
The overall purpose of this study is to determine whether the oral medication dimethyl fumarate is an effective treatment for obstructive sleep apnea in patients who are unable, unwilling, or uneager to use positive airway…
- Conditions
- Obstructive Sleep Apnea, OSA, Sleep Apnea
- Trial name
- NCT02438137
- Testing
- Dimethyl fumarate
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Michigan
Relapsing-Remitting Multiple Sclerosis
Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF) administration or 75 mg enteric-coated ASA taken once daily…
- Trial name
- ASSURE (NCT02090413)
- Testing
- dimethyl fumarate, acetylsalicylic acid
- Where
- 21 sites in Ireland, United Kingdom
- Volunteers
- 241 people
- Sponsor
- Biogen
Multiple Sclerosis, Secondary Progressive
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive…
- Trial name
- INSPIRE (NCT02430532)
- Testing
- dimethyl fumarate
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 58 people
- Sponsor
- Biogen