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A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.

This study is currently recruiting participants.
Verified November 2017 by Flex Pharma, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03196375
First Posted: June 22, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Flex Pharma, Inc.
  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.


Condition Intervention Phase
Motor Neuron Disease Drug: FLX-787-ODT (orally disintegrating tablet) Drug: Placebo ODT Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Flex Pharma, Inc.:

Primary Outcome Measures:
  • Cramp frequency [ Time Frame: 28 days ]
    Cramp frequency measured over the 28-day treatment period


Estimated Enrollment: 120
Actual Study Start Date: July 28, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: FLX-787-ODT (orally disintegrating tablet)
FLX-787-ODT taken three times daily for 28 days
Placebo Comparator: Placebo Comparator Drug: Placebo ODT
Placebo ODT taken three times daily for 28 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196375


Contacts
Contact: Jennifer Szegda 617-874-1821 jszegda@flex-pharma.com

Locations
United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Angelina Cooper    480-882-5564    Angelina.Cooper@HonorHealth.com   
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Nicola Haakonsen    303-724-4644    Nicola.haakonsen@ucdenver.edu   
United States, District of Columbia
GW Medical Faculty Associates Inc. Recruiting
Washington, District of Columbia, United States, 20037
Contact: Lindsey Covington    202-741-2745    licovington@mfa.gwu.edu   
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Arijana Draganovic    904-953-6912    mayofloridaALSresearch@mayo.edu   
University of South Florida Health Recruiting
Tampa, Florida, United States, 33612
Contact: Brittany Harvey    813-974-9413      
United States, Indiana
Indiana University Neuroscience Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sandra Guingrich    317-963-7382    sguingri@iu.edu   
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Andrew Heim    913-945-9926    aheim2@kumc.edu   
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Kristen Riley    410-955-8511    kriley15@jhmi.edu   
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Shara Holzberg    646-797-8592    Holzbergs@hss.edu   
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mozhdeh Marandi    336-713-8577    mmarandi@wakehealth.edu   
United States, Oregon
Providence Brain and Spine Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Kimberly Goslin    503-215-8580    kimberly.goslin@providence.org   
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Ruth Stewart    717-531-0003 ext 287666    rstewart@pennstatehealth.psu.edu   
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: David Lacomis    412-647-1706    lacomisd@upmc.edu   
United States, Texas
UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Pamela Kittrell    210-450-0524    kittrellp@uthscsa.edu   
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Shannon Lucy    802-656-4582    Shannon.lucy@med.uvm.edu   
United States, Washington
Saint Luke's Rehabilitation Institute Recruiting
Spokane, Washington, United States, 99202
Contact: Douglas Weeks    509-473-6234    WeeksDL@st-lukes.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lynn Wheeler    414-805-9307    lwheeler@mcw.edu   
Sponsors and Collaborators
Flex Pharma, Inc.
Investigators
Principal Investigator: Bjorn Oskarsson, MD Mayo Clinic Jacksonville Florida
  More Information

Responsible Party: Flex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03196375     History of Changes
Other Study ID Numbers: FLX-787-203
First Submitted: June 20, 2017
First Posted: June 22, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Flex Pharma, Inc.:
Motor Neuron Disease
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Amyotrophic Lateral Sclerosis
Primary Lateral Sclerosis
Progressive Muscular Atrophy
Muscle cramps
Muscle cramping
ALS
MND
PMA
PLS
FLX-787

Additional relevant MeSH terms:
Motor Neuron Disease
Muscle Cramp
Spasm
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms