A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Motor Neuron Disease

In brief

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.

Key facts

Study ID

NCT03196375

Run by

Flex Pharma, Inc.

People needed

54

Starts

2017-07-28

Expected to finish

2018-07-27

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• California Pacific Medical Center — Sacramento, California, United States
• University of California - Davis — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• GW Medical Faculty Associates Inc. — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of South Florida Health — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University Neuroscience Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Guilford Neurologic Associates — Greensboro, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Providence Brain and Spine Institute — Portland, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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