A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
- Conditions
- Motor Neuron Disease
- Interventions
- Drug: Placebo ODTDrug: FLX-787-ODT (orally disintegrating tablet)
- Registration Number
- NCT03196375
- Lead Sponsor
- Flex Pharma, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 54
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Comparator Placebo ODT - Experimental FLX-787-ODT (orally disintegrating tablet) -
- Primary Outcome Measures
Name Time Method Cramp frequency 28 days Cramp frequency measured over the 28-day treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Indiana University Neuroscience Center
🇺🇸Indianapolis, Indiana, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
GW Medical Faculty Associates Inc.
🇺🇸Washington, District of Columbia, United States
University of South Florida Health
🇺🇸Tampa, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Austin Neuromuscular Center
🇺🇸Austin, Texas, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Saint Luke's Rehabilitation Institute
🇺🇸Spokane, Washington, United States
California Pacific Medical Center
🇺🇸Sacramento, California, United States
Hospital for Special Care
🇺🇸New Britain, Connecticut, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Baylor Scott and White Health
🇺🇸Round Rock, Texas, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Guilford Neurologic Associates
🇺🇸Greensboro, North Carolina, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of California - Davis
🇺🇸Sacramento, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Providence Brain and Spine Institute
🇺🇸Portland, Oregon, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
The University of Utah
🇺🇸Salt Lake City, Utah, United States
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States