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. Participants will also be contacted by telephone at various time points during the 3 months to assess health and well-being.
Official Title: A Study to Assess FLX-787 in Subjects with Motor Neuron Disease Experiencing Muscle Cramps.
Official Website: www.commendstudy.com
Read more at ClinicalTrials.gov
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of Motor Neuron Disease (MND) [including ALS, PLS, or PMA
- Expected survival > 6 months
- Weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes)
Exclusion Criteria:
- 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
If you would like to learn more about the COMMEND Study, visit www.commendstudy.com or contact us at the number below. Contacting us does not mean that you are required to take part in the study.