Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Aspirin 650mg Oral Capsule; Drug: Acetaminophen Tablet 650mg; Other: Placebo

• Registration Number: NCT03824938
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-04-30
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Results First Submitted: 2023-02-14
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Results First Posted: 2023-10-27
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin 650mg Oral Capsule	Aspirin 650 mg capsule by mouth, single dose
Acetaminophen	Acetaminophen Tablet 650mg	Acetaminophen 650 mg capsule by mouth, single dose
Placebo	Placebo	Placebo 650 mg capsule by mouth, single dose

Primary Outcome Measures

Name	Time	Method
Time-to-exhaustion	from start of exercise test until self-reported exhaustion, up to 30 minutes	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.
Exercise-induced Body Temperature Change	from start of exercise test until self-reported exhaustion, up to 30 minutes	Change in body temperature from pre- to post- maximal exercise test.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States