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

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:

NCT03196375

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