Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Multiple Sclerosis Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824938
• Other study ID #: AAAS2529
• Secondary ID: 1R21HD091836-01A
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of relapsing-remitting MS

• self-reported heat-sensitivity to exercise

• Expanded Disability Status Scale (EDSS) total score = 6.0

• exacerbation-free (and no use of corticosteroids) for 6 weeks prior

• BMI = 40

Exclusion Criteria:

• prior history of significant head injury, stroke, or other neurological disease/disorder

• current daily use of antipyretics or pain medication

• currently in a major depressive episode

• vascular disease of the legs, uncontrolled high blood pressure

• uncontrolled diabetes mellitus or problem with blood sugar levels

• contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal or severe gynecological bleeding)

• tarry stool or known fecal occult blood

• uncontrolled syndrome of asthma, rhinitis, or nasal polyps

• contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C Virus)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Aspirin 650mg Oral Capsule
A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-exhaustion	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.	from start of exercise test until self-reported exhaustion, up to 30 minutes
Primary	Exercise-induced Body Temperature Change	Change in body temperature from pre- to post- maximal exercise test.	from start of exercise test until self-reported exhaustion, up to 30 minutes