Study Purpose:
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.
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS , Primary Lateral Sclerosis (PLS)
Study Type:
Interventional
Type of Intervention:
Drug Trial
Intervention Name:
Placebo:
Yes
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Bjorn Oskarsson, MD, Mayo Clinic Jacksonville Florida
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Jennifer Szegda / email hidden; JavaScript is required / 617-893-9898
Study Sponsor:
Flex Pharma, Inc.
Participant Duration:
3 months
Estimated Enrollment:
120
Estimated Study Start Date:
07 / 28 / 2017
Estimated Study Completion Date:
06 / 30 / 2018
Posting Last Modified Date:
08 / 06 / 2018
Date Study Added to neals.org:
08 / 02 / 2017
Minimum Age:
18
Can participants use Riluzole?
Yes
Inclusion Criteria:
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)
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
Honor Health Research Institute
Angelina Cooper / 480-882-5564 / email hidden; JavaScript is required
Scottsdale, Arizona
85251
United States
Mayo Clinic
Mark Ross / 480-301-6711 / email hidden; JavaScript is required
Scottsdale, Arizona
85259
United States
California Pacific Medical Center
Dallas Forshew / 415-309-5178 / email hidden; JavaScript is required
Sacramento, California
94115
United States
University of Colorado
Nicola Haakonsen / 303-724-4644 / email hidden; JavaScript is required
Aurora, Colorado
80045
United States
Hospital for Special Care
Agnes Koczon-Jaremko / 860-612-6356 / email hidden; JavaScript is required
New Britain, Connecticut
06053
United States
GW Medical Faculty Associates Inc.
Lindsey Covington / 202-741-2745 / email hidden; JavaScript is required
Washington, District of Columbia
20037
United States
Mayo Clinic
Arijana Draganovic / 904-953-6912 / email hidden; JavaScript is required
Jacksonville, Florida
32224
United States
University of South Florida Health
Brittany Harvey / 813-974-9413
Tampa, Florida
33612
United States
Indiana University Neuroscience Center
Sandra Guingrich / 317-963-7382 / email hidden; JavaScript is required
Indianapolis, Indiana
46202
United States
University of Kansas Medical Center
Jennifer Tuttle / 913-588-5703 / email hidden; JavaScript is required
Kansas City, Kansas
66160
United States
Johns Hopkins Hospital
Kristen Riley / 410-955-8511 / email hidden; JavaScript is required
Baltimore, Maryland
21205
United States
Saint Louis University
Susan Eller / 314-977-4900 / email hidden; JavaScript is required
Saint Louis, Missouri
63104
United States
Hospital for Special Surgery
Shara Holzberg / 646-797-8592 / email hidden; JavaScript is required
New York, New York
10021
United States
Guilford Neurologic Associates
Marsela Ferko / 336-516-9106 / email hidden; JavaScript is required
Greensboro, North Carolina
27405
United States
Wake Forest University
Mozhdeh Marandi / 336-713-8577 / email hidden; JavaScript is required
Winston-Salem, North Carolina
27157
United States
Providence Brain and Spine Institute
Kimberly Goslin / 503-215-8580 / email hidden; JavaScript is required
Portland, Oregon
97213
United States
Penn State Milton S. Hershey Medical Center
Ruth Stewart / 717-531-0003 ext 287666 / email hidden; JavaScript is required
Hershey, Pennsylvania
17033
United States
Temple University
Kathleen Hatala / 215-707-4171 / email hidden; JavaScript is required
Philadelphia, Pennsylvania
19140
United States
University of Pittsburgh
David Lacomis / 412-647-1706 / email hidden; JavaScript is required
Pittsburgh, Pennsylvania
15213
United States
UT Health San Antonio
Pamela Kittrell / 210-450-0524 / email hidden; JavaScript is required
San Antonio, Texas
78229
United States
The University of Utah
Teresa Janecki / 801-581-3724 / email hidden; JavaScript is required
Salt Lake City, Utah
84112
United States
University of Vermont Medical Center
Shannon Lucy / 802-656-4582 / email hidden; JavaScript is required
Burlington, Vermont
05405
United States
Saint Luke's Rehabilitation Institute
Douglas Weeks / 509-473-6234 / email hidden; JavaScript is required
Spokane, Washington
99202
United States
Medical College of Wisconsin
Lynn Wheeler / 414-805-9307 / email hidden; JavaScript is required
Milwaukee, Wisconsin
53226
United States