Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

NCT03824938 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: AAAS25291R21HD091836-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

exercise; aspirin; cooling; antipyretic

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Aspirin

EXPERIMENTAL

Aspirin 650 mg capsule by mouth, single dose

Drug: Aspirin 650mg Oral Capsule

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen 650 mg capsule by mouth, single dose

Drug: Acetaminophen Tablet 650mg

Placebo

PLACEBO COMPARATOR

Placebo 650 mg capsule by mouth, single dose

Other: Placebo

Interventions

Aspirin 650mg Oral Capsule DRUG

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

Also known as: Aspirin

Aspirin

Acetaminophen Tablet 650mg DRUG

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

Also known as: Acetaminophen

Acetaminophen

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 29076760 BACKGROUND

• 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.

  PMID: 33191260 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Aspirin; Acetaminophen

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Victoria M. Leavitt, MD
• Organization: Columbia University Irving Medical Center

vl3227@cumc.columbia.edu

212-342-1351

Study Officials

• Victoria M Leavitt, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study biostatistician will derive the randomization schedule. Study pharmacy will make assignments and maintain blinding until data analysis is complete for the full sample.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a within-subject design double-blind RCT in which each participant receives 1 of 3 treatments at 3 timepoints (i.e., 3 separate days separated by 1-week washout periods).

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 31, 2019
• Study Start: April 30, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available from close of the study until 2031.
• Access Criteria: Qualified researchers, upon request to study PI

Locations

US (1)