The primary
objective of this study is to determine whether BG00012 (dimethyl
fumarate, DMF, Tecfidera™) taken over 12 months is effective in reducing
Multiple Sclerosis-related fatigue, as measured by 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 as follows: To describe variation from
baseline in fatigue scores effects on motor and cognitive function or
Fatigue Scale for Motor and Cognitive Functions (FSMC) and fatigue
severity (Fatigue Severity Scale [FSS]) at 1, 3, and 6 months in
participants receiving standard of care (SOC) treatment; To investigate
changes from baseline in fatigue effects on motor and cognitive function
(FSMC) and fatigue severity (Fatigue Severity Scale [FSS]) at 1, 3, 6,
9, and 12 months in participants receiving BG00012; To assess the impact
of BG00012 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] or the 15-dimensional health-related
quality of life [15D HRQoL] questionnaire), depression (Beck Depression
Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness
Scale [ESS]) at 6 and 12 months in participants receiving BG00012; To
examine whether an association exists between fatigue and baseline
demographics and disease characteristics (e.g., age, sex, disease
duration, baseline disease activity, treatment history, expanded
disability status scale [EDSS] score, and PROs); and To assess any
changes in fatigue-related medication use.
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