Study Stopped
Sponsor
A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
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
1 other identifier
interventional
54
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2017
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2018
CompletedAugust 29, 2018
August 1, 2018
12 months
June 20, 2017
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cramp frequency
Cramp frequency measured over the 28-day treatment period
28 days
Study Arms (2)
Experimental
EXPERIMENTALPlacebo Comparator
PLACEBO COMPARATORInterventions
FLX-787-ODT taken three times daily for 28 days
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Honor Health Research Institute
Scottsdale, Arizona, 85251, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
California Pacific Medical Center
Sacramento, California, 94115, United States
University of California - Davis
Sacramento, California, 95817, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Colorado
Aurora, Colorado, 80045, United States
Hospital for Special Care
New Britain, Connecticut, 06053, United States
GW Medical Faculty Associates Inc.
Washington D.C., District of Columbia, 20037, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University of South Florida Health
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University Neuroscience Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27405, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Providence Brain and Spine Institute
Portland, Oregon, 97213, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Austin Neuromuscular Center
Austin, Texas, 78756, United States
Baylor Scott and White Health
Round Rock, Texas, 78665, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
The University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05405, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Saint Luke's Rehabilitation Institute
Spokane, Washington, 99202, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bjorn Oskarsson, MD
Mayo Clinic Jacksonville Florida
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 22, 2017
Study Start
July 28, 2017
Primary Completion
July 27, 2018
Study Completion
July 27, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08