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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Primary Lateral Sclerosis (PLS)

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Bjorn Oskarsson, MD, Mayo Clinic Jacksonville Florida

Clinicaltrials.gov ID (11 digit #):

NCT03196375

Neals Affiliated?

No

Coordinating Center Contact Information


Jennifer Szegda / .(JavaScript must be enabled to view this email address) / 617-893-9898
.(JavaScript must be enabled to view this email address)

Full Study Summary:

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:

01/05/2018

Date Study Added to alsconsortium.org:

08/02/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    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

  • Site Contact Information

    Honor Health Research Institute
    Angelina Cooper / .(JavaScript must be enabled to view this email address) / 480-882-5564
    Scottsdale, Arizona 85251
    United States

    Mayo Clinic
    Mark Ross / .(JavaScript must be enabled to view this email address) / 480-301-6711
    Scottsdale, Arizona 85259
    United States

    California Pacific Medical Center
    Dallas Forshew / .(JavaScript must be enabled to view this email address) / 415-309-5178
    Sacramento, California 94115
    United States

    University of Colorado
    Nicola Haakonsen / .(JavaScript must be enabled to view this email address) / 303-724-4644
    Aurora, Colorado 80045
    United States

    Hospital for Special Care
    Agnes Koczon-Jaremko / .(JavaScript must be enabled to view this email address) / 860-612-6356
    New Britain, Connecticut 06053
    United States

    GW Medical Faculty Associates Inc.
    Lindsey Covington / .(JavaScript must be enabled to view this email address) / 202-741-2745
    Washington , District of Columbia 20037
    United States

    University of South Florida Health
    Brittany Harvey / 813-974-9413
    Tampa, Florida 33612
    United States

    Mayo Clinic
    Arijana Draganovic / .(JavaScript must be enabled to view this email address) / 904-953-6912
    Jacksonville, Florida 32224
    United States

    Indiana University Neuroscience Center
    Sandra Guingrich / .(JavaScript must be enabled to view this email address) / 317-963-7382
    Indianapolis, Indiana 46202
    United States

    University of Kansas Medical Center
    Jennifer Tuttle / .(JavaScript must be enabled to view this email address) / 913-588-5703
    Kansas City, Kansas 66160
    United States

    Johns Hopkins Hospital
    Kristen Riley / .(JavaScript must be enabled to view this email address) / 410-955-8511
    Baltimore, Maryland 21205
    United States

    Saint Louis University
    Susan Eller / .(JavaScript must be enabled to view this email address) / 314-977-4900
    Saint Louis, Missouri 63104
    United States

    Hospital for Special Surgery
    Shara Holzberg / .(JavaScript must be enabled to view this email address) / 646-797-8592
    New York, New York 10021
    United States

    Guilford Neurologic Associates
    Marsela Ferko / .(JavaScript must be enabled to view this email address) / 336-516-9106
    Greensboro, North Carolina 27405
    United States

    Wake Forest University
    Mozhdeh Marandi / .(JavaScript must be enabled to view this email address) / 336-713-8577
    Winston-Salem, North Carolina 27157
    United States

    Providence Brain and Spine Institute
    Kimberly Goslin / .(JavaScript must be enabled to view this email address) / 503-215-8580
    Portland, Oregon 97213
    United States

    Penn State Milton S. Hershey Medical Center
    Ruth Stewart / .(JavaScript must be enabled to view this email address) / 717-531-0003 ext 287666
    Hershey, Pennsylvania 17033
    United States

    Temple University
    Kathleen Hatala / .(JavaScript must be enabled to view this email address) / 215-707-4171
    Philadelphia, Pennsylvania 19140
    United States

    University of Pittsburgh
    David Lacomis / .(JavaScript must be enabled to view this email address) / 412-647-1706
    Pittsburgh , Pennsylvania 15213
    United States

    UT Health San Antonio
    Pamela Kittrell / .(JavaScript must be enabled to view this email address) / 210-450-0524
    San Antonio, Texas 78229
    United States

    The University of Utah
    Teresa Janecki / .(JavaScript must be enabled to view this email address) / 801-581-3724
    Salt Lake City, Utah 84112
    United States

    University of Vermont Medical Center
    Shannon Lucy / .(JavaScript must be enabled to view this email address) / 802-656-4582
    Burlington, Vermont 05405
    United States

    Saint Luke's Rehabilitation Institute
    Douglas Weeks / .(JavaScript must be enabled to view this email address) / 509-473-6234
    Spokane, Washington 99202
    United States

    Medical College of Wisconsin
    Lynn Wheeler / .(JavaScript must be enabled to view this email address) / 414-805-9307
    Milwaukee, Wisconsin 53226
    United States