drugset / Trial / NCT03824938
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Phase 3
Completed
60 enrolled
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedCrossoverSingle-blindTreatment
Summary
This study investigates the use of aspirin as an exercise pre-treatment to reduce overheating and exhaustion, which may potentially allow many more people with multiple sclerosis to participate in and benefit from exercise. The design is double-blind, within-subject, with three arms: participants will receive one of three treatments at three separate study visits: aspirin, acetaminophen, and placebo, followed by completion of a maximal exercise test.
Timeline
- Start
- 2019-04-30
- Primary completion
- 2022-02-28
- Completion
- 2022-02-28
Publications
- Background Leavitt VM, Blanchard AR, Guo CY, Gelernt E, Sumowski JF, Stein J. Aspirin is an effective pretreatment for exercise in multiple sclerosis: A double-blind randomized controlled pilot trial. Mult Scler. 2018 Oct;24(11):1511-1513. doi: 10.1177/1352458517739138. Epub 2017 Oct 27.
- Kever A, Nelson KE, Aguerre IM, Riley CS, Boehme A, Lee NW, Strauss Farber R, Levin SN, Stein J, Leavitt VM. ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis. BMJ Open. 2020 Nov 14;10(11):e039691. doi: 10.1136/bmjopen-2020-039691.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 650 mg | Oral |
| Subject | Aspirin | Small molecule | 650 mg | Oral |