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

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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.


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
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601 Elmwood Avenue
Rochester, New York 14642
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Gainesville, Florida 32610
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101 Jessup Hall
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4201 Belfort Road
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500 University Dr
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