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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    24
  • sponsor
    DAS-MG, Inc
Updated on 17 April 2021

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.

Description

Methodology: 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.

Study Design: The clinical trial will be conducted over a 6-week treatment period.

  • Group A: Patients currently taking pyridostigmine and experiencing pyridostigmine-related gastrointestinal (GI) adverse events (AEs) within the past 7 days
  • Group B: Patients not currently taking pyridostigmine due to GI AEs or that had their dose reduced due to pyridostigmine related GI AEs Group A will be enrolled in the study and randomized to either the control (pyridostigmine+ placebo) or the test group (pyridostigmine + ondansetron) and treated for 6 weeks. Following enrolment, patients may (if needed) titrate up their pyridostigmine dose at the investigator's discretion each week to the highest dose deemed appropriate, tolerable and safe by the Investigator.

Group B patients not currently taking pyridostigmine due to GI AEs will initiate pyridostigmine at a dose determined by the investigator based on the patient's history and may titrate as deemed tolerable and safe by Investigator during screening; patients on a reduced dose due to pyridostigmine related GI AEs may titrate pyridostigmine as deemed tolerable and safe by the investigator during screening. If patients in Group B experience GI AEs that fulfil enrolment criteria, along with all other inclusion/exclusion criteria, they will be enrolled into the study at that dose and randomized to either the control (pyridostigmine+ placebo) or the test group (pyridostigmine + ondansetron) and treated for 6 weeks. Following enrolment, patients may (if needed) titrate up their pyridostigmine dose at the investigator's discretion each week to the highest dose deemed appropriate, tolerable and safe by the Investigator.

Details
Condition Myasthenia Gravis, Myasthenia Gravis generalised, Myasthenia Gravis (Chronic Weakness)
Treatment DAS-001
Clinical Study IdentifierNCT04226170
SponsorDAS-MG, Inc
Last Modified on17 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

diagnosed with myasthenia gravis and who are currently taking pyridostigmine and experienced pyridostigmine-related GI side effects within the past 7 days
GSRS rating of at least Moderate discomfort on questions 5, 11, and 12
Subjects must be willing and able to complete a GI symptom diary within a consistent timeframe on a daily basis
Subjects must be able to tolerate a pyridostigmine dose of 30mg TID
Must be clinically stable in judgement of treating neurologists for past 3 months
Must have AchR antibody positive MG
Subjects must be able to swallow liquids
Subjects must be in 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

Key exclusion criteria
The criteria for exclusion of a subject from enrollment in the study are as
follows
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
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
Patients currently being treated with narcotics
Patients being treated with aminoglycoside antibiotics, which are contraindicated in myasthenia gravis
Patients unable to be contacted in case of an emergency
Intake of an investigational drug within 30 days of study entry
Pregnancy and women of childbearing potential not willing to follow the birth control requirements as described in the informed consent or breastfeeding
History or presence of obstructive pulmonary disease or urinary obstruction (contraindication for pyridostigmine)
This use of selective serotonin reuptake inhibitors (SSRI's)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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