A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
NCT ID: NCT03196375
Last Updated: 2018-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2017-07-28
2018-07-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
FLX-787-ODT (orally disintegrating tablet)
FLX-787-ODT taken three times daily for 28 days
Placebo Comparator
Placebo ODT
Placebo ODT taken three times daily for 28 days
Interventions
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FLX-787-ODT (orally disintegrating tablet)
FLX-787-ODT taken three times daily for 28 days
Placebo ODT
Placebo ODT taken three times daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Flex Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bjorn Oskarsson, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Jacksonville Florida
Locations
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Honor Health Research Institute
Scottsdale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
California Pacific Medical Center
Sacramento, California, United States
University of California - Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
GW Medical Faculty Associates Inc.
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida Health
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University Neuroscience Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Hospital for Special Surgery
New York, New York, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Providence Brain and Spine Institute
Portland, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Austin Neuromuscular Center
Austin, Texas, United States
Baylor Scott and White Health
Round Rock, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Saint Luke's Rehabilitation Institute
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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FLX-787-203
Identifier Type: -
Identifier Source: org_study_id
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