Abandoned trial: only 2 patients tested for stomach relief in muscle disease

NCT ID NCT04226170

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 ยท Last updated Jun 26, 2026

Summary

This small, early-stage trial tested whether adding ondansetron (an anti-nausea drug) to pyridostigmine (a standard myasthenia gravis treatment) could reduce stomach side effects like nausea, vomiting, or diarrhea. Only 2 people with anti-AchR positive myasthenia gravis were enrolled before the study was terminated. The goal was to improve quality of life by making the main treatment more tolerable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ondansetron and pyridostigmine
What this could lead to
If it works, this could help manage stomach side effects from standard myasthenia gravis medication, making treatment easier to tolerate.
What could go wrong
The trial was terminated early with only 2 participants, so results are very limited. It is unclear if the combination is safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

2 people

The number who actually took part.

Started

Nov 2023

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Male and female subjects aged 18 years old and up who have been diagnosed with anti-AchR antibody positive myasthenia gravis. 2. Subjects can be either: currently taking pyridostigmine and after Lead-in Period experience dose limiting GI AEs related to pyridostigmine (must include nausea, vomiting or diarrhea) during Lead-in 3. Subjects must be willing and able to complete a GI symptom diary within a consistent timeframe on a daily basis. 4. Must be clinically stable in judgement of treating neurologists for past 3 months. 5. Must be positive for acetylcholine receptor antibodies. 6. Subjects must be able to swallow liquid. 7. Subjects must be in otherwise good health as determined by their medical history, physical examination, vital signs, and laboratory tests. A subject with a medical abnormality may be included only if the investigator or designee considers that the abnormality will not introduce significant additional risk to the subject's health or interfere with study objectives. 8. Subjects must have signed an informed consent form indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions. Exclusion criteria: 1. Any acute or chronic diseases which are associated with GI distress (such as nausea, vomiting, or diarrhea), which could interfere with the subjects' safety during the trial, expose them to undue risk, or interfere with the study objectives. 2. History or presence of hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 3. History of substance abuse, known drug addiction, or positive test for drugs of abuse or alcohol. 4. Patients currently using marijuana for any reason (medical or recreational). 5. Known hypersensitivity to pyridostigmine, or to ondansetron or similar 5-HT3 serotonin receptor antagonists. 6. ECG changes including QT interval prolongation and congenital long QT syndrome. Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmia's or other medicinal products that lead to QT prolongation. 7. Treatment with drugs affecting peripheral cholinergic transmission within 1 month of study entry (with the exception of pyridostigmine). 8. Subjects unlikely to co-operate during the study, and/or be questionably compliant in the opinion of the investigator. 9. Patients currently being treated with narcotics. 10. Patients being treated with aminoglycoside antibiotics, which are contraindicated in myasthenia gravis. 11. Patients unable to be contacted in case of an emergency. 12. Intake of an investigational drug within 30 days of study entry. 13. Pregnancy and women of childbearing potential not willing to follow the birth control requirements as described in the informed consent or breastfeeding. 14. History or presence of obstructive pulmonary disease or urinary obstruction (contraindication for pyridostigmine). 15. This use of selective serotonin reuptake inhibitors (SSRIs).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

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