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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254199
Recruitment Status : Terminated (Sponsor)
First Posted : August 18, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Flex Pharma, Inc.

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.


Condition or disease Intervention/treatment Phase
Charcot-Marie-Tooth Disease Drug: FLX-787-ODT (orally disintegrating tablet) Drug: Placebo ODT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018


Arm Intervention/treatment
Experimental: Experimental Drug: FLX-787-ODT (orally disintegrating tablet)
FLX-787-ODT taken three times daily for 28 days

Placebo Comparator: Placebo Comparator Drug: Placebo ODT
Placebo ODT taken three times daily for 28 days




Primary Outcome Measures :
  1. Cramp frequency [ Time Frame: 28 days ]
    Cramp frequency measured over the 28-day treatment period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254199


Locations
Show Show 20 study locations
Sponsors and Collaborators
Flex Pharma, Inc.
Investigators
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Principal Investigator: Nicolas Johnson, MD University of Utah
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Responsible Party: Flex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03254199    
Other Study ID Numbers: FLX-787-204
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flex Pharma, Inc.:
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
Additional relevant MeSH terms:
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Muscle Cramp
Tooth Diseases
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Spasm
Stomatognathic Diseases
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms