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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196375
Recruitment Status : Terminated (Sponsor)
First Posted : June 22, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Flex Pharma, Inc.

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018


Arm Intervention/treatment
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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Hide Hide 35 study locations
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United States, Arizona
Honor Health Research Institute
Scottsdale, Arizona, United States, 85251
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
California Pacific Medical Center
Sacramento, California, United States, 94115
University of California - Davis
Sacramento, California, United States, 95817
University of California San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Hospital for Special Care
New Britain, Connecticut, United States, 06053
United States, District of Columbia
GW Medical Faculty Associates Inc.
Washington, District of Columbia, United States, 20037
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
University of South Florida Health
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University Neuroscience Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Guilford Neurologic Associates
Greensboro, North Carolina, United States, 27405
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Providence Brain and Spine Institute
Portland, Oregon, United States, 97213
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Temple University
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Austin Neuromuscular Center
Austin, Texas, United States, 78756
Baylor Scott and White Health
Round Rock, Texas, United States, 78665
UT Health San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
The University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05405
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Saint Luke's Rehabilitation Institute
Spokane, Washington, United States, 99202
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Flex Pharma, Inc.
Investigators
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Principal Investigator: Bjorn Oskarsson, MD Mayo Clinic Jacksonville Florida

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Responsible Party: Flex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03196375    
Other Study ID Numbers: FLX-787-203
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Muscle Cramp
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Spasm
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms