Clinical trial

Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)

Name

AAAS2529

Description

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.

Trial arms

Trial start

2019-04-30

Estimated PCD

2022-02-28

Trial end

2022-02-28

Status

Completed

Phase

Early phase I

Treatment

Aspirin 650mg Oral Capsule

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

Arms:

Aspirin

Other names:

Aspirin

Acetaminophen Tablet 650mg

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

Arms:

Acetaminophen

Other names:

Acetaminophen

Placebo

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

Arms:

Placebo

Size

Primary endpoint

Time-to-exhaustion

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

Exercise-induced Body Temperature Change

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

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Study biostatistician will derive the randomization schedule. Study pharmacy will make assignments and maintain blinding until data analysis is complete for the full sample.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-10-27

1 organization

2 products

1 indication

Organization

Product

Indication

Product