Status:
TERMINATED
A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.
Lead Sponsor:
Flex Pharma, Inc.
Conditions:
Charcot-Marie-Tooth Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 pr...
Eligibility Criteria
Inclusion
- Presence of symptoms of CMT since at least 6 months prior to Screening, and confirmed diagnosis of CMT as defined by:
- Genetic confirmation of a mutation known to cause CMT, or
- 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
- 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
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03254199
Start Date
October 16 2017
End Date
July 27 2018
Last Update
August 29 2018
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Hospital for Special Care
New Britain, Connecticut, United States, 06053
4
University of Florida
Gainesville, Florida, United States, 32607