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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
FLX-787-ODT taken three times daily for 28 days
Placebo ODT taken three times daily for 28 days
Mayo Clinic
Scottsdale, Arizona, United States
University of Colorado
Cramp frequency
Cramp frequency measured over the 28-day treatment period
Time frame: 28 days
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Aurora, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brighman and Women's Hospital
Boston, Massachusetts, United States
...and 10 more locations