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 Motor Neuron Disease

Study Purpose:

The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with Motor Neuron Disease [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)] 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 approximately 30 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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Primary Lateral Sclerosis (PLS)

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, not yet recruiting

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Bjorn Oskarsson, MD, Mayo Clinic Jacksonville Florida

Clinicaltrials.gov ID (11 digit #):

NCT03196375

Neals Affiliated?

No

Coordinating Center Contact Information


Jennifer Szegda / .(JavaScript must be enabled to view this email address) / 617-893-9898
.(JavaScript must be enabled to view this email address)

Full Study Summary:

Study Sponsor:

Flex Pharma, Inc.

Participant Duration:

3 months

Estimated Enrollment:

120

Estimated Study Start Date:

06/30/2017

Estimated Study Completion Date:

06/30/2018

Posting Last Modified Date:

08/02/2017

Date Study Added to alsconsortium.org:

08/02/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:
    Documented diagnosis of Motor Neuron Disease (MND) [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)]
    Expected survival > 6 months
    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 laryngospasm or significant swallowing problems
    Presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or G-tube
    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

  • Site Contact Information