A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
Status: | Terminated |
---|---|
Conditions: | Other Indications, Neurology, Metabolic |
Therapuetic Areas: | Neurology, Pharmacology / Toxicology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/31/2018 |
Start Date: | July 28, 2017 |
End Date: | July 27, 2018 |
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
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.
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.
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
We found this trial at
35
sites
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-647-1706
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-3724
University of Utah Research is a major component in the life of the U benefiting...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 842-792-9186
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-0003
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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355 West 16th Street
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Phone: 317-963-7382
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200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-8326
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-945-9934
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-805-9307
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Phone: 646-797-8592
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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1801 N Broad St
Philadelphia, Pennsylvania 19122
Philadelphia, Pennsylvania 19122
(215) 204-7000
Phone: 215-707-4171
Temple University Temple University is many things to many people. A place to pursue life's...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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2323 Sacramento Street
Sacramento, California 94115
Sacramento, California 94115
Phone: 415-309-5178
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1 Shields Ave
Sacramento, California 95616
Sacramento, California 95616
(530) 752-1011
Phone: 916-734-0968
University of California-Davis As we begin our second century, UC Davis is poised to become...
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10510 North 92nd Street
Scottsdale, Arizona 85251
Scottsdale, Arizona 85251
Phone: 480-882-5564
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