A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Biogen
- Primary Endpoint
- Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMF
Study Overview
Brief Summary
The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]), health-related quality of life (Short Form Health Survey [SF-12]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS]) at 6 and 12 months in participants receiving DMF; To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale [EDSS] score, and PROs); To assess any changes in fatigue-related medication use.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •NOTE: Other protocol-defined Inclusion/Exclusion Criteria May Apply
Arms & Interventions
dimethyl fumarate
DMF at a dose of 120 mg twice a day (BID) for the first 7 days and 240 mg BID for the remainder of study period (up to 12 months)
Intervention: dimethyl fumarate (Drug)
Outcomes
Primary Outcomes
Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMF
Time Frame: 12 months
FSMC is a 20-item questionnaire and produces a score between 1 and 5 for each scored question (ranging from "does not apply at all" to "applies completely"). Items are summed to generate a total score and transformed to a scale with a range of 20 to 100, where higher scores indicate higher levels of fatigue
Secondary Outcomes
- Mean change from baseline in work productivity as assessed by WPAI-MS, in participants receiving DMF(Baseline and 6, 12 months)
- Mean change from baseline in quality of life as assessed by SF-12 in participants receiving DMF(Baseline and 6, 12 months)
- Correlation of fatigue with baseline demographics and disease characteristics(Baseline and up to 12 months)
- Mean change from baseline in fatigue as assessed by FSS in participants receiving DMF(Baseline and 1, 3, 6, 9 and 12 months)
- Mean change from baseline in depression as assessed by BDI-FS in participants receiving DMF(Baseline and 6, 12 months)
- Change in MS-related fatigue (FSMC) status(Baseline and up to 12 months)
- Mean change from baseline in fatigue as assessed by FSMC in participants receiving DMF(Baseline and 1, 3, 6, 9 and 12 months)
- Mean change from baseline in sleepiness assessed by ESS in participants receiving DMF(Baseline and 6, 12 months)
- Proportion of participants with reduced dose or discontinuation of fatigue-related medications(6 and 12 months)