Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate)
Naïve to dimethyl fumarate and fumaric acid esters
You may not be if
Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7 consecutive days of gastrointestinal-related symptomatic therapy
Known active malignancies
History of anaphylaxis or severe allergic reactions or known drug hypersensitivity
Current use of B vitamin supplements
In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use
Clareo Health | Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
