A Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia Gravis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- DAS-MG, Inc
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with change in the gastrointestinal (GI) side effects
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The only unblinded study member will be the pharmacist
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
treatment
ondansetron + pyridostigmine
干预措施: DAS-001 (Drug)
Placebo
placebo+ pyridostigmine
干预措施: DAS-001 (Drug)
结局指标
主要结局
Number of participants with change in the gastrointestinal (GI) side effects
时间窗: 6 weeks
difference in GI side effects as measured by the GSRS-self (Gastrointestinal System Rating Scale - self-administered)
次要结局
- 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)