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Clinical trial

Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate (DMF)-Treated Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) (ASSURE)

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Last updated:14th Mar 2014

The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (ASA) taken twice a day (BID) with BG00012 (dimethyl fumarate, DMF) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with BG00012 administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with BG00012 in the clinical practice setting..

Secondary objectives this study in this study population are: To evaluate the safety and tolerability of BG00012 administered with and without enteric-coated ASA in the clinical practice setting; To evaluate the impact of BG00012 administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.

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Study start date 2014-03-14

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