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
Naïve to fumaric acid esters (e.g. DMF, Fumaderm, compounded fumarates)
Diagnosed with RRMS and satisfies the approved therapeutic indication for DMF
Participants of childbearing potential must practice effective contraception and be willing and able to continue contraception throughout the study
Ability to complete the tolerability scales accurately using the electronic diary (eDiary) and ability to complete the paper Flushing Diaries
You may not be if
Inability or unwillingness to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation
One or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study or otherwise makes the subject an unsuitable candidate for study participation. The prevailing product labels for both DMF and ASA should be used as guides
Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible)
Chronic use (≥7 consecutive days) of ASA- or nonsteroidal anti-inflammatory drugs (NSAID)-containing products within the month prior to enrollment in the study
A known intolerance to ASA
Active peptic ulceration or a history of peptic ulceration, hemophilia or other clotting disorders, or gout
Known hypersensitivity reactions (e.g., bronchospasm, rhinitis, urticaria) in response to ASA or NSAID administration
Impaired hepatic or renal function, in the opinion of the investigator
Female subject is pregnant, lactating, or will be attempting to become pregnant during the Double-Blind Period (first 12 weeks) of the study
Currently participating in another interventional clinical trial
