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, 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 with 2 groups. * Group A: Patients currently taking pyridostigmine and experiencing pyridostigmine-related gastrointestinal (GI) adverse events (AEs) within the past 14 days. * Group B: Patients not currently taking pyridostigmine due to a documented history of GI AEs. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
ondansetron + pyridostigmine
University of Kansas Medical Center
Kansas City, Kansas, United States
Number of participants with change in the gastrointestinal (GI) side effects
difference in GI side effects as measured by the GSRS-self (Gastrointestinal System Rating Scale - self-administered)
Time frame: 6 weeks
Number of participants with change in the side effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events
Time frame: 6 weeks
Number of participants with change in in physical examine
physical examination changes General appearance,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Time frame: 6 weeks
Number of participants with change in in clinical laboratory evaluations
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein, Albumin,Hematocrit Hemoglobin Platelet count Red blood cell (RBC) count WBC count WBC differential Mean cell volume (MCV) Mean cell hemoglobin (MCH) MCH concentration (MCHC)
Time frame: 6 weeks
Number of participants with change in Electrocardiography (ECG)
ECG (standard digital 12-lead in singlicate)
Time frame: 6 weeks
Plasma concentrations of pyridostigmine
Cmax
Time frame: 6 weeks
Plasma concentrations of ondansetron
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Cmax
Time frame: 6 weeks