A Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia Gravis
Overview
- Phase
- Phase 2
- Intervention
- DAS-001
- Conditions
- Myasthenia Gravis
- Sponsor
- DAS-MG, Inc
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Number of participants with change in the gastrointestinal (GI) side effects
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
treatment
ondansetron + pyridostigmine
Intervention: DAS-001
Placebo
placebo+ pyridostigmine
Intervention: DAS-001
Outcomes
Primary Outcomes
Number of participants with change in the gastrointestinal (GI) side effects
Time Frame: 6 weeks
difference in GI side effects as measured by the GSRS-self (Gastrointestinal System Rating Scale - self-administered)
Secondary Outcomes
- Number of participants with change in in physical examine(6 weeks)
- Number of participants with change in Electrocardiography (ECG)(6 weeks)
- Plasma concentrations of pyridostigmine(6 weeks)
- Plasma concentrations of ondansetron(6 weeks)
- Number of participants with change in the side effects(6 weeks)
- Number of participants with change in in clinical laboratory evaluations(6 weeks)