NCT04226170

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

A Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia Gravis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: DAS-MG, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	DAS-001	ondansetron + pyridostigmine

Timeline

• Start date: 2023-11-08
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2020-01-13
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study