Phase 3
N=37
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03824938 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Time-to-exhaustion — 551.7; 331.6; 578.2 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aspirin 650mg Oral Capsule (Drug); Acetaminophen Tablet 650mg (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-exhaustion |
551.7; 331.6; 578.2 | — |
| PRIMARY Exercise-induced Body Temperature Change |
0.68; 0.006; 0.31 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03824938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.