A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03254199

Acronym

COMMIT

Enrollment

Registered

2017-08-18

Start date

2017-10-16

Completion date

2018-07-27

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Charcot-Marie-Tooth Disease

Keywords

Charcot-Marie-Tooth, CMT, Muscle Cramps, Muscle Cramping, FLX-787, Hereditary Sensory and Motor Neuropathy, Neurogenetic disorder, Nervous System Malformations, Nervous System Diseases, Neurodegenerative Diseases, Neuromuscular Diseases

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 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.

Interventions

DRUGFLX-787-ODT (orally disintegrating tablet)

FLX-787-ODT taken three times daily for 28 days

DRUGPlacebo ODT

Placebo ODT taken three times daily for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cramp frequency	28 days	Cramp frequency measured over the 28-day treatment period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026