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NCT Number: NCT07440446

Effect of Acetominophen an 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunter College Physical Therapy department

New York, 10065, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1000mg acetaminophen or placebo

Drug

Acetaminophen or placebo

Primary outcomes

  1. Treadmill walk time to fatigue

    Time frame: From enrollment to end of treatment at 1 week

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Herbert Karpatkion, PT, DSc, NCS, MSCS

CONTACT

[email protected]

19176080610

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Registry information

Official study title

Effect of Antipyretics in Gait Fatigue in Multiple Sclerosis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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