Myasthenia Gravis Clinical Trial
Official title:
A Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia Gravis
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.
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. ;
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