Effect of Acetominophen an Gait Fatigue in Multiple Sclerosis

March 16, 2026 updated by: Hunter College of City University of New York

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Hunter College Physical Therapy department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ambulatory persons with MS

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Any current or recent exacerbations
  • Any adverse reaction to antipyretics
  • Recent use of steroids
  • Any non-MS conditions that interfere with walking performance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Persons with Multiple Sclerosis
acetaminophen or placebo
Drug: 1000mg acetaminophen or placebo
Acetaminophen or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treadmill walk time to fatigue
Time Frame: From enrollment to end of treatment at 1 week
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)
from enrollment to end of data collection for each participant will be one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter College of City University of New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB ID:2025-0566 Hunter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all de-identified data will be shared upon request

IPD Sharing Time Frame

for 7 years following termination of data collection

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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