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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD091836-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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 exhaustion for persons with MS, through its antipyretic mechanism. Participants will be seen at our laboratory for maximal exercise tests on three separate days. At each session, they will be given one of three treatments: aspirin, acetaminophen (a drug that is anti-inflammatory but not antipyretic, thereby allowing for isolation of the antipyretic action of aspirin), and placebo. Primary outcome is increased time to exhaustion, secondary outcome is reduced body temperature increase during exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Aspirin 650 mg capsule by mouth, single dose |
|
| Acetaminophen | Active Comparator | Acetaminophen 650 mg capsule by mouth, single dose |
|
| Placebo | Placebo Comparator | Placebo 650 mg capsule by mouth, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 650mg Oral Capsule | Drug | A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-exhaustion | Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for >/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria. | from start of exercise test until self-reported exhaustion, up to 30 minutes |
| Exercise-induced Body Temperature Change | Change in body temperature from pre- to post- maximal exercise test. | from start of exercise test until self-reported exhaustion, up to 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria M Leavitt, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29076760 | Background | Leavitt VM, Blanchard AR, Guo CY, Gelernt E, Sumowski JF, Stein J. Aspirin is an effective pretreatment for exercise in multiple sclerosis: A double-blind randomized controlled pilot trial. Mult Scler. 2018 Oct;24(11):1511-1513. doi: 10.1177/1352458517739138. Epub 2017 Oct 27. | |
| 33191260 | Derived | Kever A, Nelson KE, Aguerre IM, Riley CS, Boehme A, Lee NW, Strauss Farber R, Levin SN, Stein J, Leavitt VM. ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis. BMJ Open. 2020 Nov 14;10(11):e039691. doi: 10.1136/bmjopen-2020-039691. |
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Raw data for primary and secondary outcomes will be shared with qualified researchers upon reasonable request to study PI.
Data will be available from close of the study until 2031.
Qualified researchers, upon request to study PI
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Out of the 60 enrolled, 37 completed at least one visit.
Out of the 97 screened, 60 were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Aspirin, Then Acetaminophen | First session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. Second session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. Third session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. |
| FG001 | Placebo First, Then Acetaminophen, Then Aspirin | First session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. Second session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. Third session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. |
| FG002 | Aspirin First, Then Placebo, Then Acetaminophen | First session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. Second session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. Third session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. |
| FG003 | Aspirin First, Then Acetaminophen, Then Placebo | First session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. Second session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. Third session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. |
| FG004 | Acetaminophen First, Then Placebo, Then Aspirin | First session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. Second session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. Third session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. |
| FG005 | Acetaminophen First, Then Aspirin, Then Placebo | First session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. Second session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. Third session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | ASPIRE trial sample characteristics of the 37 active study participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-to-exhaustion | Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for >/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria. | Posted | Mean | Standard Deviation | seconds | from start of exercise test until self-reported exhaustion, up to 30 minutes |
|
Up to 30 days after study completion, an average of 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria M. Leavitt, MD | Columbia University Irving Medical Center | 212-342-1351 | vl3227@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 7, 2021 | May 22, 2023 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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This is a within-subject design double-blind RCT in which each participant receives 1 of 3 treatments at 3 timepoints (i.e., 3 separate days separated by 1-week washout periods).
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Study biostatistician will derive the randomization schedule. Study pharmacy will make assignments and maintain blinding until data analysis is complete for the full sample.
| Acetaminophen Tablet 650mg | Drug | A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. |
|
|
| Placebo | Other | A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. |
|
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Acetaminophen | Participants received acetaminophen 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test. |
|
|
| Primary | Exercise-induced Body Temperature Change | Change in body temperature from pre- to post- maximal exercise test. | Posted | Mean | Standard Deviation | degrees Fahrenheit | from start of exercise test until self-reported exhaustion, up to 30 minutes |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Aspirin | Participants received aspirin 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Acetaminophen | Participants received acetaminophen 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |