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Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

NCT03824938 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-27

Study results available
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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

Interventions

DRUG

Aspirin 650mg Oral Capsule

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

DRUG

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Victoria M Leavitt, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2022-02-28
Completion
2022-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824938 on ClinicalTrials.gov