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Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

CompletedPhase 3

Sponsor: Columbia University

Conditions: Multiple Sclerosis

Interventions: Aspirin 650mg Oral Capsule, Acetaminophen Tablet 650mg, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (1)

New York, New York, United States