Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis

Description

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.

Conditions

Myasthenia Gravis

Study Overview

Study Details

Study overview

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.

A Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia Gravis

Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis

Condition
Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

DAS-MG, Inc,

Study Record Dates

2026-09-30