A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.
Status: | Terminated |
---|---|
Conditions: | Other Indications, Neurology, Dental, Metabolic |
Therapuetic Areas: | Dental / Maxillofacial Surgery, Neurology, Pharmacology / Toxicology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/31/2018 |
Start Date: | October 16, 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 Charcot-Marie-Tooth Disease
The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with
Charcot-Marie-Tooth disease (CMT) 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 20 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.
Charcot-Marie-Tooth disease (CMT) 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 20 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:
- Presence of symptoms of CMT since at least 6 months prior to Screening, and confirmed
diagnosis of CMT as defined by:
1. Genetic confirmation of a mutation known to cause CMT, or
2. Clinical and electrophysiological evidence of CMT and a genetic confirmation in a
family member. Clinical features include length dependent sensory and motor loss,
with sensorimotor axonal or demyelinating changes on a nerve conduction study.
- 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 significant swallowing problems
- 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
20
sites
630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-305-0405
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-4218
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-494-7394
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-1267
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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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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4202 E Fowler Ave
Tampa, Florida 33620
Tampa, Florida 33620
(813) 974-2011
Phone: 813-974-9413
University of South Florida The University of South Florida is a high-impact, global research university...
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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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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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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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