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 RRMS and satisfies the therapeutic indication as described in the local label.
Have a stable EDSS (as assessed by the Investigator) and been on the same (type and dosage) standard of care (SOC) first-line treatment for at least 6 months.
If taking antidepressants, amphetamine, modafinil, or fampridine (Fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the Baseline Visit.
FSMC total score ≥43 (mild fatigue) at Baseline.
As perceived by the Investigator, have the ability to comply with all requirements of the study protocol.
You may not be if
Diagnosis of major depression, as identified by the Investigator.
Diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
Treatment of MS relapse within 90 days prior to study enrollment.
History of a positive test result for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody.
Impaired hepatic or renal function, as perceived by the Investigator.
Any prior treatment with DMF (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, T cell or T-cell receptor vaccination, or any therapeutic monoclonal antibody.
Current enrollment in any other clinical studies.
Known to suffer from narcolepsy or another significant sleep disorder.
Comorbidity that may have an impact on fatigue.
Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Clareo Health | Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate
