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
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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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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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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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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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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