Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2015-02
- Completion
- 2015-11
Outcome
Missed primary endpoint
registry analysis (superiority or other test); DMF + ASA-Placebo BID vs DMF + ASA 150 mg BID; Difference in percentage -1.3 (95% CI -10.8 to 8.3) NCT02090413 ↗
registry analysis (superiority or other test); DMF + ASA-Placebo BID vs DMF + ASA 75 mg QAM; Difference in percentage 4.9 (95% CI -2.6 to 12.4) NCT02090413 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 75 mg | — |
| Subject | Aspirin | Small molecule | 150 mg | — |
| Subject | dimethyl fumarate | Unknown | 240 mg | — |