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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03051646 |
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Date of registration:
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08/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis
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Scientific title:
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A Placebo-controlled Double Blind Crossover Trial of Acetylsalicylic Acid as a Pre-treatment for Exercise in Multiple Sclerosis |
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Date of first enrolment:
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January 13, 2017 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03051646 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Victoria Leavitt, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistant Professor of Neuropsychology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- RRMS
- self report of overheating during exercise
- low physical disability (EDSS total score 4.5 or less); fully ambulatory without aid
- exacerbation-free (and no use of corticosteroids) for 6 weeks prior
- BMI 35 or lower
Exclusion Criteria:
- uncontrolled hypertension or vascular disease of the legs
- current medications for heart or blood pressure problem
- prior history of head injury, stroke, or other neurological disease/disorder
- currently taking antipyretics or pain medication daily
- presence of major depressive disorder or other psychiatric diagnosis
- formally diagnosed sleep disorder
- pulmonary disease, heart disease or other heart problem
- diabetes mellitus or problem with blood sugar levels
- lower body weakness or reliance on supportive devices for walking (as indicated
through EDSS)
- counter indications to aspirin use: history of confirmed peptic ulcer,
gastrointestinal or sever gynecological bleeding; tarry stool or fecal occult blood;
syndrome of asthma, rhinitis or nasal polyps
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Overheating
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Fatigue
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Intervention(s)
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Drug: Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit
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Drug: Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit
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Primary Outcome(s)
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Change in Time to Exhaustion
[Time Frame: ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period.]
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Secondary Outcome(s)
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Exercise-induced Body Temperature Increase
[Time Frame: Effect of treatment on body temperature in a single session (i.e., pre- to post- exercise test) to be completed within a 14-day period]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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