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Aspirin for Exercise in Multiple Sclerosis (ASPIRE) (ASPIRE)

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Aspirin 650mg Oral Capsule

Acetaminophen Tablet 650mg

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring exercise, aspirin, cooling, antipyretic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Aspirin

Acetaminophen

Placebo

Arm Description

Aspirin 650 mg capsule by mouth, single dose

Acetaminophen 650 mg capsule by mouth, single dose

Placebo 650 mg capsule by mouth, single dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exercise-induced body temperature increase

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

Full Information

NCT ID

NCT03824938

First Posted

January 9, 2019

Last Updated

September 13, 2022

Sponsor

Columbia University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03824938

Brief Title

Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

April 30, 2019 (Actual)

Primary Completion Date

February 28, 2022 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

exercise, aspirin, cooling, antipyretic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Model Description

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).

Masking

Outcomes Assessor

Masking Description

Study biostatistician will derive the randomization schedule. Study pharmacy will make assignments and maintain blinding until data analysis is complete for the full sample.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspirin

Arm Type

Experimental

Arm Description

Aspirin 650 mg capsule by mouth, single dose

Arm Title

Acetaminophen

Arm Type

Active Comparator

Arm Description

Acetaminophen 650 mg capsule by mouth, single dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 650 mg capsule by mouth, single dose

Intervention Type

Drug

Intervention Name(s)

Aspirin 650mg Oral Capsule

Other Intervention Name(s)

Aspirin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Acetaminophen Tablet 650mg

Other Intervention Name(s)

Acetaminophen

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time-to-exhaustion

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Exercise-induced body temperature increase

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria M Leavitt, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Raw data for primary and secondary outcomes will be shared with qualified researchers upon reasonable request to study PI.

IPD Sharing Time Frame

Data will be available from close of the study until 2031.

IPD Sharing Access Criteria

Qualified researchers, upon request to study PI

Citations:

PubMed Identifier

29076760

Citation

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.

Results Reference

background

PubMed Identifier

33191260

Citation

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.

Results Reference

derived

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Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

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