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Clinical trial

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With BG00012 or Standard of Care (TECNERGY)

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Last updated:14th May 2014

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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Study start date 2014-05-14

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