Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis (NCT04226170) | Clinical Trial Compass
TerminatedPhase 2
Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis
Stopped: lack of enrollment
United States2 participantsStarted 2023-11-08
Plain-language summary
This is a phase II, single center, randomized, double-blind, placebo-controlled, study in patients with a diagnosis of anti-AchR antibody positive myasthenia gravis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female subjects aged 18 years old and up who have been diagnosed with anti-AchR antibody positive myasthenia gravis.
✓. Subjects can be either:
✓. Subjects must be willing and able to complete a GI symptom diary within a consistent timeframe on a daily basis.
✓. Must be clinically stable in judgement of treating neurologists for past 3 months.
✓. Must be positive for acetylcholine receptor antibodies.
✓. Subjects must be able to swallow liquid.
✓. 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.
✓. 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
✕. 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.
✕. History or presence of hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
What they're measuring
1
Number of participants with change in the gastrointestinal (GI) side effects
✕. History of substance abuse, known drug addiction, or positive test for drugs of abuse or alcohol.
✕. Patients currently using marijuana for any reason (medical or recreational).
✕. Known hypersensitivity to pyridostigmine, or to ondansetron or similar 5-HT3 serotonin receptor antagonists.
✕. 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.
✕. Treatment with drugs affecting peripheral cholinergic transmission within 1 month of study entry (with the exception of pyridostigmine).
✕. Subjects unlikely to co-operate during the study, and/or be questionably compliant in the opinion of the investigator.