Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: multiple sclerosis flushing aspirin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
Healthy volunteers: no

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

Secondary objectives of this study are: to evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; to evaluate the impact of DMF 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.

Detailed description:

Arms:
arm 1: DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA 150 mg is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.) arm 2: DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA 75 mg is taken in the morning (QAM) and ASA-Placebo is taken in the evening (QPM) from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.) arm 3: DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA-Placebo is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)

Interventions: intervention 1: dimethyl fumarate intervention 2: acetylsalicylic acid intervention 3: ASA-Placebo
Intervention descriptions: intervention 1: None intervention 2: enteric-coated capsule intervention 3: matched placebo

Protocol document: