Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04226170
Study type	Interventional
Source	DAS-MG, Inc
Contact	Martine Francis, BA
Phone	301-343-8894
Email	martine@mafinc.com
Status	Recruiting
Phase	Phase 2
Start date	April 8, 2021
Completion date	April 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms