Effect of Acetominophen an Gait Fatigue in Multiple Sclerosis

NCT07440446 | Not Yet Recruiting

• 1 other identifier: IRB ID:2025-0566 Hunter
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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? 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.

Conditions

Multiple Sclerosis

Keywords

Fatigue

Outcome Measures

Primary Outcomes (2)

• Treadmill walk time to fatigue

  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)

  from enrollment to end of data collection for each participant will be one week

Study Arms (1)

Persons with Multiple Sclerosis

acetaminophen or placebo

Drug: 1000mg acetaminophen or placebo

Interventions

1000mg acetaminophen or placebo DRUG

Acetaminophen or placebo

Persons with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ambulatory persons with MS

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hunter College of City University of New York: lead

Study Sites (1)

Hunter College Physical Therapy department

New York, New York, 10065, United States

Location

Related Publications (4)

• Šilarová, A., Hvid, L. G., Hradílek, P., & Dalgas, U. (2024). Exercise-induced heat sensitivity in patients with multiple sclerosis: Definition, prevalence, etiology, and management-A scoping review. Multiple Sclerosis and Related Disorders, 90, 105827.

  BACKGROUND

• (3) Bouchiba, M., Turki, M., Zarzissi, S., Zghal, F., Trabelsi, O., Rebai, H., & Bouzid, M. A. (2025). Acute acetaminophen ingestion improves the recovery of neuromuscular fatigue following simulated soccer match-play. Journal of Science and Medicine in Sport, 28(3), 189-197

  BACKGROUND

• Morgan 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.

  PMID: 29332237 BACKGROUND

• Leavitt 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.

  PMID: 38413464 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Herbert Karpatkion, PT, DSc, NCS, MSCS

CONTACT

19176080610; hkarpatk@hunter.cuny.edu

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: for 7 years following termination of data collection

Locations

US (1)