Status:
COMPLETED
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Detailed 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 exh...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03824938
Start Date
April 30 2019
End Date
February 28 2022
Last Update
October 27 2023
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032