Clinical trials: Tecfidera
Multiple Sclerosis, Relapsing-remitting
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis
The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting multiple sclerosis (MS) under routine…
- Trial name
- NCT05366036
- Testing
- No Intervention
- Where
- 20 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- Eisai Korea Inc.
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
Multiple Sclerosis, Relapsing-Remitting
Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP)…
- Trial name
- TEC-ADHERE (NCT04221191)
- Testing
- Dimethyl Fumarate, PSP
- Where
- 63 sites in France
- Volunteers
- 353 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
Healthy
PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
The primary objective of the study is to determine the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in healthy volunteers receiving TECFIDERA™ (dimethyl…
- Trial name
- NCT01915901
- Testing
- bismuth subsalicylate (Pepto-Bismol®), dimethyl fumarate (DMF)
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- 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
Healthy
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
- Trial name
- 109HV108 (NCT01453426)
- Testing
- BG00012 Dose 1, BG00012 Dose 2
- Where
- 2 sites in Australia, China
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes
This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of…
- Trial name
- NCT03284970
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
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
Psoriasis
Study of the Effects of the Organism on Monomethyl Fumarate (MMF) After the Administration of LAS41008
The purpose of this study is to determine how the organism affects MMF (metabolite of dimethyl fumarate [DMF]) after single oral dose administration of LAS41008 120 mg gastroresistant tablet and Fumaderm® 120 mg gastro-resistant…
- Trial name
- LAS41008 (NCT02955693)
- Testing
- LAS41008 120 mg / Fumaderm® 120 mg
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Almirall, S.A.
Relapsing Multiple Sclerosis
A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)
The goal of this clinical trial is to evaluate the efficacy and safety] in [subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis…
- Trial name
- NCT07138833
- Testing
- Dimethyl Fumarate Enteric-coated Capsules
- Volunteers
- 50 people
- Sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
Multiple Sclerosis
Study of Utilization Patterns of Dimethyl Fumarate in Germany
The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF…
- Trial name
- NCT02969304
- Testing
- dimethyl fumarate
- Where
- Germany
- Volunteers
- 930 people
- Sponsor
- Biogen
Relapsing-remitting Multiple Sclerosis (RRMS)
A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
This is a randomized, controlled, multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of rocbrutinib (LP-168), an oral BTK inhibitor, in subjects with paramagnetic rim lesion (PRL)-positive…
- Trial name
- NCT07776743
- Testing
- Rocbrutinib, Dimethyl Fumarate
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
Multiple Sclerosis
Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS
This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients
- Trial name
- STHENOS (NCT04788615)
- Testing
- Ofatumumab, First line DMT
- Where
- 41 sites in France, Germany and 2 more
- Volunteers
- 185 people
- Sponsor
- Novartis Pharmaceuticals
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
Multiple Sclerosis
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
- Trial name
- NCT04022473
- Testing
- Bafiertam, Tecfidera
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Multiple Sclerosis
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with…
- Trial name
- NCT05767736
- Testing
- Diroximel Fumarate, Dimethyl Fumarate, Disease-Modifying Therapies (DMTs)
- Where
- United States
- Volunteers
- 10,500 people
- Sponsor
- Biogen
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia.
- Trial name
- Lympho-TEC (NCT04756687)
- Testing
- Dimethyl fumarate
- Where
- 32 sites in France
- Volunteers
- 1,507 people
- Sponsor
- Biogen
Multiple Sclerosis
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
The primary objective of the study is to assess the efficacy of DMF in Chinese participants with RMS at Week 48. The secondary objectives of the study are to assess the efficacy and safety of DMF in Chinese participants with RMS.
- Trial name
- NCT05658484
- Testing
- Dimethyl fumarate
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Biogen