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NCT03051646 · ClinicalTrials.gov registry record · Early Phase 1
Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis
A Early Phase 1 study of Fatigue and Overheating, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03051646 is a Early Phase 1 study of Fatigue and Overheating that has completed, run by Columbia University. The registered enrollment target is 12 participants, below the 218-participant average among 109 other Fatigue trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03051646, a Early Phase 1 study of Fatigue and Overheating, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Exercise has many benefits for people with multiple sclerosis (MS), such as improved physical symptoms, mood, fatigue, and cognition. However, many people with MS refrain from exercising because of the discomfort of exhaustion and overheating that they experience. This study investigates the use of aspirin before exercise as a treatment to reduce overheating and exhaustion, thereby availing many more people with MS the opportunity to benefit from exercise. The investigators recently published the first-ever report of elevated body temperature in relapsing-remitting MS (RRMS) patients relative to healthy controls, and elevated temperature was linked to worse fatigue. This finding that body temperature is elevated and linked to fatigue in RRMS lays the groundwork for a paradigm shift in our understanding and treatment of fatigue. That is, the focus shifts from exogenous to endogenous temperature, and from stimulant medication to cooling treatments. A recent study comparing healthy adults to adults with MS showed that whereas exercise increased body temperature in both groups, only in the MS group was it correlated with exhaustion. The reason for this may relate to the elevation in resting body temperature in relapsing-remitting MS (RRMS) patients relative to healthy controls. The finding is clinically meaningful, as elevated body temperature was correlated with worse fatigue in patients. Exercise Aim: To determine whether pretreatment with ASA (compared to placebo: within subject crossover design) before exercise results in improved exercise performance (i.e., increased time-to-exhaustion). The investigators hypothesize that participants will tolerate exercise for longer after taking ASA than placebo. This hypothesis is based on a) demonstrated efficacy of antipyretic for reducing body temperature during exercise in healthy controls, b) demonstrated efficacy of antipyretic for reducing fatigue in non-exercising MS patients, and c) demonstrated efficacy of elaborate
Conditions Studied
Interventions
- DRUG Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit
- DRUG Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit
Study Locations (1)
New York
- Columbia University Medical Center, MS Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-01-13 |
| Est. Completion | 2017-05-10 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03051646
The ClinicalTrials.gov registry entry for NCT03051646 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 109 other Fatigue trials with a reported enrollment target (94% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Fatigue appearing as the primary indexed condition, and to 2 interventions - of which Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit is the first listed.
NCT03051646 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03051646 about?
NCT03051646 is a clinical study titled "Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis". Exercise has many benefits for people with multiple sclerosis (MS), such as improved physical symptoms, mood, fatigue, and cognition. However, many people with MS refrain from exercising because of the discomfort of exhaustion and overheating that they experience. This study investigates the use of ...
What is the current status of trial NCT03051646?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2017-01-13. Estimated completion is 2017-05-10.
What conditions does trial NCT03051646 study?
This clinical trial studies the following conditions: Fatigue, Overheating.
What interventions are being tested in trial NCT03051646?
The interventions under investigation include: Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit (DRUG), Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit (DRUG).
Who is sponsoring clinical trial NCT03051646?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03051646 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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