Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Acetaminophen; Aspirin

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)