A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects With Motor Neuron Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 34
- 主要终点
- Cramp frequency
研究概览
简要总结
The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with Motor Neuron Disease [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)] experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo.
Approximately 120 participants in approximately 30 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented diagnosis of Motor Neuron Disease (MND) [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)]
- •Expected survival > 6 months
- •Weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes)
排除标准
- •Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers
- •Presence of laryngospasm or significant swallowing problems
- •Presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or G-tube
- •Unable or unwilling to discontinue medications for cramps and/or opiates
- •Inability to tolerate a spicy sensation in the mouth or stomach
- •Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol
- •Intention to change the current level of tobacco use or use of nicotine-containing products (i.e., new smokers or those actively trying to quit may not enrolled)
- •Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening
研究组 & 干预措施
Experimental
干预措施: FLX-787-ODT (orally disintegrating tablet) (Drug)
Placebo Comparator
干预措施: Placebo ODT (Drug)
结局指标
主要结局
Cramp frequency
时间窗: 28 days
Cramp frequency measured over the 28-day treatment period
次要结局
未报告次要终点