NCT03824938

Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Persons with multiple sclerosis benefit from exercise, but many avoid it because of exhaustion and overheating. This randomized controlled trial (RCT) tests aspirin as a method to increase time to exhaustion for persons with MS, through its antipyretic mechanism. Participants will be seen at our laboratory for maximal exercise tests on three separate days. At each session, they will be given one of three treatments: aspirin, acetaminophen (a drug that is anti-inflammatory but not antipyretic, thereby allowing for isolation of the antipyretic action of aspirin), and placebo. Primary outcome is increased time to exhaustion, secondary outcome is reduced body temperature increase during exercise.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Aspirin 650mg Oral Capsule	A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
DRUG	Acetaminophen Tablet 650mg	A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
OTHER	Placebo	A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.

Timeline

• Start date: 2019-04-30
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2019-01-31
• Last updated: 2023-10-27
• Results posted: 2023-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study