Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

NCT ID: NCT03824938

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2022-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aspirin

Aspirin 650 mg capsule by mouth, single dose

Group Type: EXPERIMENTAL

Aspirin 650mg Oral Capsule

Intervention Type: DRUG

A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.

Acetaminophen

Acetaminophen 650 mg capsule by mouth, single dose

Group Type: ACTIVE_COMPARATOR

Acetaminophen Tablet 650mg

Intervention Type: DRUG

A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.

Placebo

Placebo 650 mg capsule by mouth, single dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.

Interventions

Aspirin 650mg Oral Capsule

A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.

Intervention Type: DRUG

Acetaminophen Tablet 650mg

A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.

Intervention Type: DRUG

Placebo

A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.

Intervention Type: OTHER

Other Intervention Names

Aspirin; Acetaminophen

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Victoria M. Leavitt

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria M Leavitt, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29076760 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33191260 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1R21HD091836-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS2529

Identifier Type: -

Identifier Source: org_study_id