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

Description

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 Start Date

October, 16 2017

Estimated Completion Date

August 2018

Interventions

  • Drug: FLX-787-ODT (orally disintegrating tablet)
  • Drug: Placebo ODT

Study ID

Flex Pharma, Inc. -- FLX-787-204

Status

Recruiting

Trial ID

NCT03254199

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

120

Sponsor

Flex Pharma, Inc.

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (19)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Peter James 617-643-4218 PFJAMES@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Peter James 617-643-4218 PFJAMES@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Peter James 617-643-4218 PFJAMES@mgh.harvard.edu
Hospital for Special Care - New Britain, Connecticut 98.7 miles Agnes KoczonJaremko 860-612-6356 Jaremko@hfsc.org
Hospital for Special Care - New Britain, Connecticut 98.7 miles Agnes KoczonJaremko 860-612-6356 Jaremko@hfsc.org
Hospital for Special Care - New Britain, Connecticut 98.7 miles Agnes KoczonJaremko 860-612-6356 Jaremko@hfsc.org
Hospital for Special Care - New Britain, Connecticut 98.7 miles Agnes KoczonJaremko 860-612-6356 Jaremko@hfsc.org
Hospital for Special Care - New Britain, Connecticut 98.7 miles Agnes KoczonJaremko 860-612-6356 Jaremko@hfsc.org
University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 Bharvey1@health.usf.edu
University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 Bharvey1@health.usf.edu
University of South Florida - Tampa, Florida 1,178.7 miles Brittany Harvey 813-974-9413 Bharvey1@health.usf.edu
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Ayla McCalley 913-945-9937 amccalley2@kumc.edu
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Ayla McCalley 913-945-9937 amccalley2@kumc.edu
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Ayla McCalley 913-945-9937 amccalley2@kumc.edu
Saint Lukes Rehabilitation Institute - Spokane, Washington 2,261.3 miles Douglas Weeks 509-473-6234 WeeksDL@st-lukes.org
Saint Lukes Rehabilitation Institute - Spokane, Washington 2,261.3 miles Douglas Weeks 509-473-6234 WeeksDL@st-lukes.org
Saint Lukes Rehabilitation Institute - Spokane, Washington 2,261.3 miles Douglas Weeks 509-473-6234 WeeksDL@st-lukes.org
Saint Lukes Rehabilitation Institute - Spokane, Washington 2,261.3 miles Douglas Weeks 509-473-6234 WeeksDL@st-lukes.org
Saint Lukes Rehabilitation Institute - Spokane, Washington 2,261.3 miles Douglas Weeks 509-473-6234 WeeksDL@st-lukes.org

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