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
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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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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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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