NCT03824938: ASPIRE

Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Completed Phase 3 Results posted Last updated 27 October 2023

What this trial tests

Phase 3 trial testing Aspirin 650mg Oral Capsule in Multiple Sclerosis in 60 participants. Completed in 28 February 2022.

Timeline

30 April 2019

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	Columbia University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	30 April 2019
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Aspirin 650mg Oral Capsule — full drug profile →
• Acetaminophen Tablet 650mg — full drug profile →
• Placebo

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Columbia University

Who can join

Adults 18 to 70, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-to-exhaustion Primary · from start of exercise test until self-reported exhaustion, up to 30 minutes

Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for \>/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria.

Group	Value	95% CI
Placebo	551.7	± 78.4
Aspirin	331.6	± 76.6
Acetaminophen	578.2	± 82.1

Exercise-induced Body Temperature Change Primary · from start of exercise test until self-reported exhaustion, up to 30 minutes

Change in body temperature from pre- to post- maximal exercise test.

Group	Value	95% CI
Placebo	0.68	± 0.35
Aspirin	0.006	± 0.32
Acetaminophen	0.31	± 0.35

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis.
   Kever A, Nelson KE, Aguerre IM, Riley CS, et al · · 2020 · cited 2× · PMID 33191260 · DOI 10.1136/bmjopen-2020-039691