Multiple SclerosisPhase 3ASPIRENCT03824938
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
A Phase 3 study testing Aspirin 650mg Oral Capsule and Acetaminophen Tablet 650mg in people with Multiple Sclerosis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aspirin 650mg Oral Capsule and Acetaminophen Tablet 650mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 28 Feb 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)
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.
Read the 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 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Aspirin 650mg Oral Capsule, Acetaminophen Tablet 650mg, Placebo
- Keywords
- exercise, aspirin, cooling, antipyretic
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 650mg Oral CapsuleDrug
Also called Aspirin
A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Acetaminophen Tablet 650mgDrug
Also called Acetaminophen
A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
PlaceboOther
A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin 650 mg capsule by mouth, single dose Receives: Drug: Aspirin 650mg Oral Capsule |
| Acetaminophen | Active comparator | Acetaminophen 650 mg capsule by mouth, single dose Receives: Drug: Acetaminophen Tablet 650mg |
| Placebo | Placebo comparator | Placebo 650 mg capsule by mouth, single dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from start of exercise test until self-reported exhaustion, up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start30 Apr 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Victoria M. Leavitt, Columbia University
- Investigators
- Victoria M Leavitt, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824938
- Sponsor's protocol ID
- AAAS2529
- Other IDs
- 1R21HD091836-01A1
- Acronym
- ASPIRE
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2019
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data for primary and secondary outcomes will be shared with qualified researchers upon reasonable request to study PI.
Publications
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.
PubMed 29076760Kever 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.
PubMed 33191260
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT03824938
- Acronym / sponsor ID
- ASPIRE / AAAS2529
- Conditions
- Multiple Sclerosis
- Keywords
- exercise, aspirin, cooling, antipyretic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin 650mg Oral CapsuleAspirin 650 mg capsule by mouth, single dose |
| Acetaminophen | Active comparator | Drug: Acetaminophen Tablet 650mgAcetaminophen 650 mg capsule by mouth, single dose |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 650 mg capsule by mouth, single dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 650mg Oral CapsuleAlso: AspirinA 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test. | Drug | Aspirin |
| Acetaminophen Tablet 650mgAlso: AcetaminophenA 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test. | Drug | Acetaminophen |
| PlaceboA placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test. | Other | Placebo |
Primary outcome
Time-to-exhaustion
Time frame: from start of exercise test until self-reported exhaustion, up to 30 minutes
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.
Exercise-induced Body Temperature Change
Time frame: from start of exercise test until self-reported exhaustion, up to 30 minutes
Change in body temperature from pre- to post- maximal exercise test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29076760Leavitt 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.
- Derived from this study: PubMed 33191260Kever 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.
- Individual participant dataSharing planned: Yes. Raw data for primary and secondary outcomes will be shared with qualified researchers upon reasonable request to study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria M Leavitt, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin 650mg Oral Capsule and Acetaminophen Tablet 650mg in people with Multiple Sclerosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-exhaustion (time frame: from start of exercise test until self-reported exhaustion, up to 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.