Relapsing Remitting Multiple Sclerosis RRMS
Conditions
Interventions
The selected dose of DMF for this study is 120 mg twice daily (BID) for the
first 7 days and 240 mg BID thereafter, which is consistent with the European
Union Summary of Product Characteristics (Sm
Sponsors
Biogen Idec Research Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations 2. Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label. 3. Have a stable EDSS (as assessed by the Investigator) and have been on the same (type and dosage) standard of care first line treatment for at least 6 months. 4. 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. 5. Age *18 years at the time of informed consent 6. FSMC total score *43 (mild fatigue) at Baseline. 7. As perceived by the Investigator, have the ability to comply with all requirements of the study protocol. 8. Female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 12 weeks after their last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of major depression, as identified by the Investigator. 2. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS. 3. 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. 4. History of a relapse within 90 days prior to study enrollment or showing transient symptoms derived from a previous relapse, irrespective of time of symptom onset. 5. Treatment of MS relapse within 90 days prior to study enrollment. 6. 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. 7. Female subjects who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding. 8. Impaired hepatic or renal function, as perceived by the Investigator. 9. 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. 10. Treatment within 1 year prior to study enrollment with mitoxantrone or cyclophosphamide. 11. Treatment within 6 months prior to study enrollment with cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, intravenous immunoglobulin, plasmapheresis, cytapheresis, or another investigational drug or approved therapy for investigational use. 12. Current enrollment in any other clinical studies. 13. Known to suffer from narcolepsy or another significant sleep disorder. 14. Comorbidity that may have an impact on fatigue. 15. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: - Mean change from Baseline in MS-related fatigue (FSMC) at 12 months in subjects receiving DMF | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: - Mean change from Baseline in fatigue (FSMC and FSS) at 1, 3, 6, 9, and 12 months in subjects receiving DMF - Mean change from Baseline in work productivity, quality of life, depression, and sleepiness at 6 and 12 months in subjects receiving DMF - Change in MS-related fatigue (FSMC) status (improved [> 4.5 increase], stable [within ±4.5], and worsened [> 4.5 decrease]) - Correlation of fatigue with baseline demographics and disease characteristics - Proportion of subjects with reduced dose or discontinuation of fatigue-related medications at 6 and 12 months Exploratory: - Relationship of serum biomarker values to fatigue (change in biomarker value) | — |
Countries
Netherlands
Outcome results
None listed