Multiple SclerosisNCT07440446
Effect of Acetominophen an Gait Fatigue in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The goal of this observational study is to compare the impact of an antipyretic, acetaminophen to a placebo on gait fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: will the antipyretic effects of acetaminophen result in less gait fatigue in persons with MS?… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ambulatory persons with MS
Who may be able to join
- A definitive MS diagnosis confirmed by self-report,
- The ability to walk for 2 minutes continuously with or without assistive device ---Age 18-65
- Provide a blood test within the last 6 months to 1 year reflecting normal liver and renal profile (normal liver enzymes and normal creatinine level).
Who cannot join
- Any current or recent exacerbations
- Any adverse reaction to antipyretics
- Recent use of steroids
- Any non-MS conditions that interfere with walking performance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hunter College Physical Therapy department
New York, New York, 10065
About this study
Official title: Effect of Antipyretics in Gait Fatigue in Multiple Sclerosis
The goal of this observational study is to compare the impact of an antipyretic, acetaminophen to a placebo on gait fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: will the antipyretic effects of acetaminophen result in less gait fatigue in persons with MS? Participants will be asked to come for two sessions over a 1 week period. In the first week, subjects will be blind-randomized into either the acetaminophen or placebo group. They will then undergo a test to determine their gait speed by performing two 25 foot walks at their best comfortable pace. The walks will be 1 minute apart. The average speed from those 2 walks will be obtained. Subjects will then take either the acetaminophen or the placebo. Following a 45 minute rest period they will then get on a treadmill and will walk at the previously determined speed for as long as they can. Walking will stop if the subject can no longer maintain the speed or if they wish to no longer continue. The subjects will wear a safety harness at all times during the walk to prevent falls. Heart rate and core body temperature will be measured via skin sensors. One week later the subjects will return and repeat the procedure but this time in the opposite condition. Subjects who took the acetaminophen will take the placebo and subjects who took the placebo will take the acetaminophen. The difference between distance walked in the 2 conditions will be compared.
Read the detailed description
Persons with Multiple Sclerosis have difficulty with walking longer distances because of fatigue. The fatigue is in large part a result of heat sensitivity; during exercise the increase in metabolism results in increases in core temperature which reduces conduction through demyelinated nerves.
Medications such as Acetaminophen are antipyretic which are used to reduce temperature in persons with a fever. Antipyretics may therefore result in lowering the temperature in persons with MS and allow them to walk longer distances.
In this study, ambulatory persons with MS will be randomly assigned to receive either acetaminophen or a placebo. Participants will be blinded to which they receive. They will then perform a 25 foot walk test where they will be asked to walk 25 feet at their best comfortable speed. The walks will be 1 minute apart. The average speed of the 2 walks will be obtained. Subjects will then receive either the acetaminophen or the placebo and rest for 45 minutes so that the medication can reach peak effect, and then will walk on a treadmill at the previously obtained speed until they can no longer maintain the original speed, or they wish to stop. One week later subjects will return and take whichever pill they did not take the first time.
We hypothesize that subjects who take the antipyretic will walk for a longer period than those who took the placebo. If our hypothesis is correct, it will suggest that antipyretics should be further investigated as a means of addressing thermosensitivy leading to gait fatigue in persons with MS
- Conditions
- Multiple Sclerosis
- Being tested
- 1000mg acetaminophen or placebo
- Keywords
- Fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1000mg acetaminophen or placeboDrug
Acetaminophen or placebo
| Study group | Role | What they receive |
|---|---|---|
| Persons with Multiple Sclerosis | acetaminophen or placebo Receives: Drug: 1000mg acetaminophen or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treadmill walk time to fatigue
Measured: From enrollment to end of treatment at 1 week
Treadmill time to fatigue
Participants will walk on a treadmill until either they wish to stop, or, if they are unable to maintain a specific speed. Treadmill speed will be based on the speed they achieve during a 25 foot walk test where they would be asked to walk at their best comfortable speed over the distance of 25 feet. Subjects will receive either acetaminophen or placebo before the treadmill walk . One minute after the first treadmill walk the subjects will return and repeat the walk , this time taking whichever pill they dod not take the first time (acetaminophen or placebo)
Measured: from enrollment to end of data collection for each participant will be one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440446
- Sponsor's protocol ID
- IRB ID:2025-0566 Hunter
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all de-identified data will be shared upon request
Publications
Silarova A, Hvid LG, Hradilek P, Dalgas U. Exercise-induced heat sensitivity in patients with multiple sclerosis: Definition, prevalence, etiology, and management-A scoping review. Mult Scler Relat Disord. 2024 Oct;90:105827. doi: 10.1016/j.msard.2024.105827. Epub 2024 Aug 17.
PubMed 39213861Bouchiba M, Turki M, Zarzissi S, Zghal F, Trabelsi O, Rebai H, Bouzid MA. Acute acetaminophen ingestion improves the recovery of neuromuscular fatigue following simulated soccer match-play. J Sci Med Sport. 2025 Mar;28(3):189-197. doi: 10.1016/j.jsams.2024.11.002. Epub 2024 Nov 7.
PubMed 39572310Morgan PT, Bowtell JL, Vanhatalo A, Jones AM, Bailey SJ. Acute acetaminophen ingestion improves performance and muscle activation during maximal intermittent knee extensor exercise. Eur J Appl Physiol. 2018 Mar;118(3):595-605. doi: 10.1007/s00421-017-3794-7. Epub 2018 Jan 13.
PubMed 29332237Leavitt VM, Tozlu C, Nelson KE, Boehme AK, Donnelly JE, Aguerre I, Spinner M, Riley CS, Stein J, Onomichi K. A randomized controlled trial of oral antipyretic treatment to reduce overheating during exercise in adults with multiple sclerosis. J Neurol. 2024 May;271(5):2207-2215. doi: 10.1007/s00415-023-12147-6. Epub 2024 Feb 28.
PubMed 38413464
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antipyretics in Gait Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07440446
- Acronym / sponsor ID
- IRB ID:2025-0566 Hunter
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to compare the impact of an antipyretic, acetaminophen to a placebo on gait fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: will the antipyretic effects of acetaminophen result in less gait fatigue in persons with MS? Participants will be asked to come for two sessions over a 1 week period. In the first week, subjects will be blind-randomized into either the acetaminophen or placebo group. They will then undergo a test to determine their gait speed by performing two 25 foot walks at their best comfortable pace. The walks will be 1 minute apart. The average speed from those 2 walks will be obtained. Subjects will then take either the acetaminophen or the placebo. Following a 45 minute rest period they will then get on a treadmill and will walk at the previously determined speed for as long as they can. Walking will stop if the subject can no longer maintain the speed or if they wish to no longer continue. The subjects will wear a safety harness at all times during the walk to prevent falls. Heart rate and core body temperature will be measured via skin sensors. One week later the subjects will return and repeat the procedure but this time in the opposite condition. Subjects who took the acetaminophen will take the placebo and subjects who took the placebo will take the acetaminophen. The difference between distance walked in the 2 conditions will be compared.
Detailed description
Persons with Multiple Sclerosis have difficulty with walking longer distances because of fatigue. The fatigue is in large part a result of heat sensitivity; during exercise the increase in metabolism results in increases in core temperature which reduces conduction through demyelinated nerves.
Medications such as Acetaminophen are antipyretic which are used to reduce temperature in persons with a fever. Antipyretics may therefore result in lowering the temperature in persons with MS and allow them to walk longer distances.
In this study, ambulatory persons with MS will be randomly assigned to receive either acetaminophen or a placebo. Participants will be blinded to which they receive. They will then perform a 25 foot walk test where they will be asked to walk 25 feet at their best comfortable speed. The walks will be 1 minute apart. The average speed of the 2 walks will be obtained. Subjects will then receive either the acetaminophen or the placebo and rest for 45 minutes so that the medication can reach peak effect, and then will walk on a treadmill at the previously obtained speed until they can no longer maintain the original speed, or they wish to stop. One week later subjects will return and take whichever pill they did not take the first time.
We hypothesize that subjects who take the antipyretic will walk for a longer period than those who took the placebo. If our hypothesis is correct, it will suggest that antipyretics should be further investigated as a means of addressing thermosensitivy leading to gait fatigue in persons with MS
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Multiple Sclerosis | – | Drug: 1000mg acetaminophen or placeboacetaminophen or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ambulatory persons with MS
Key inclusion criteria (3 listed)
- A definitive MS diagnosis confirmed by self-report,
- The ability to walk for 2 minutes continuously with or without assistive device ---Age 18-65
- Provide a blood test within the last 6 months to 1 year reflecting normal liver and renal profile (normal liver enzymes and normal creatinine level).
Key exclusion criteria (4 listed)
- Any current or recent exacerbations
- Any adverse reaction to antipyretics
- Recent use of steroids
- Any non-MS conditions that interfere with walking performance.
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 |
|---|---|---|
| 1000mg acetaminophen or placeboAcetaminophen or placebo | Drug | Persons with Multiple Sclerosis |
Primary outcome
Treadmill walk time to fatigue
Time frame: From enrollment to end of treatment at 1 week
Treadmill time to fatigue
Time frame: from enrollment to end of data collection for each participant will be one week
Participants will walk on a treadmill until either they wish to stop, or, if they are unable to maintain a specific speed. Treadmill speed will be based on the speed they achieve during a 25 foot walk test where they would be asked to walk at their best comfortable speed over the distance of 25 feet. Subjects will receive either acetaminophen or placebo before the treadmill walk . One minute after the first treadmill walk the subjects will return and repeat the walk , this time taking whichever pill they dod not take the first time (acetaminophen or placebo)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 39213861Silarova A, Hvid LG, Hradilek P, Dalgas U. Exercise-induced heat sensitivity in patients with multiple sclerosis: Definition, prevalence, etiology, and management-A scoping review. Mult Scler Relat Disord. 2024 Oct;90:105827. doi: 10.1016/j.msard.2024.105827. Epub 2024 Aug 17.
- Background: PubMed 39572310Bouchiba M, Turki M, Zarzissi S, Zghal F, Trabelsi O, Rebai H, Bouzid MA. Acute acetaminophen ingestion improves the recovery of neuromuscular fatigue following simulated soccer match-play. J Sci Med Sport. 2025 Mar;28(3):189-197. doi: 10.1016/j.jsams.2024.11.002. Epub 2024 Nov 7.
- Background: PubMed 29332237Morgan PT, Bowtell JL, Vanhatalo A, Jones AM, Bailey SJ. Acute acetaminophen ingestion improves performance and muscle activation during maximal intermittent knee extensor exercise. Eur J Appl Physiol. 2018 Mar;118(3):595-605. doi: 10.1007/s00421-017-3794-7. Epub 2018 Jan 13.
- Background: PubMed 38413464Leavitt VM, Tozlu C, Nelson KE, Boehme AK, Donnelly JE, Aguerre I, Spinner M, Riley CS, Stein J, Onomichi K. A randomized controlled trial of oral antipyretic treatment to reduce overheating during exercise in adults with multiple sclerosis. J Neurol. 2024 May;271(5):2207-2215. doi: 10.1007/s00415-023-12147-6. Epub 2024 Feb 28.
- Individual participant dataSharing planned: Yes. all de-identified data will be shared upon request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hunter College of City University of New York 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herbert Karpatkion, PT, DSc, NCS, MSCS (19176080610, hkarpatk@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treadmill walk time to fatigue (time frame: From enrollment to end of treatment at 1 week). 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 NCT07440446, which also lists 4 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 17 Mar 2026.