Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Columbia University

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Acetaminophen Tablet 650mg; Other: Placebo; Drug: Aspirin 650mg Oral Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03824938

1R21HD091836-01A1 (U.S. NIH Grant/Contract)

AAAS2529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Aspirin

Experimental group

Description:

Aspirin 650 mg capsule by mouth, single dose

Treatment:

Drug: Aspirin 650mg Oral Capsule

Acetaminophen

Active Comparator group

Description:

Acetaminophen 650 mg capsule by mouth, single dose

Treatment:

Drug: Acetaminophen Tablet 650mg

Placebo

Placebo Comparator group

Description:

Placebo 650 mg capsule by mouth, single dose

Treatment:

Other: Placebo