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TerminatedNCT03196375Updated Aug 29, 2018

A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.

A Phase 2 interventional study of FLX-787-ODT (orally disintegrating tablet) and Placebo ODT in Motor Neuron Disease, sponsored by Flex Pharma, Inc.. Terminated at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Flex Pharma, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor

From the registry’s dates

  • Primary completion was Jul 2018, 8 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Motor Neuron Disease

Keywords

  • Motor Neuron Disease
  • Neurodegenerative Diseases
  • Nervous System Diseases
  • Neuromuscular Diseases
  • Amyotrophic Lateral Sclerosis
  • Primary Lateral Sclerosis
  • Progressive Muscular Atrophy
  • Muscle cramps
  • Muscle cramping
  • ALS
  • MND
  • PMA
  • PLS
  • FLX-787
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 135 are open to participants now.

This study's enrollment of 54 is above the median of 34 across 462 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Flex Pharma, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Experimental

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

  • Placebo comparator
    Placebo Comparator

    Drug: Placebo ODT

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

06

What researchers measure

Primary outcomes

  1. Cramp frequency

    Cramp frequency measured over the 28-day treatment period

    Time frame: 28 days

07

Study locations

35 sites
  • Honor Health Research Institute
    Scottsdale, Arizona 85251, United States
  • Mayo Clinic
    Scottsdale, Arizona 85259, United States
  • California Pacific Medical Center
    Sacramento, California 94115, United States
  • University of California - Davis
    Sacramento, California 95817, United States
  • University of California San Francisco
    San Francisco, California 94143, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • Hospital for Special Care
    New Britain, Connecticut 06053, United States
  • GW Medical Faculty Associates Inc.
    Washington D.C., District of Columbia 20037, United States
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
  • University of South Florida Health
    Tampa, Florida 33612, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Indiana University Neuroscience Center
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Johns Hopkins Hospital
    Baltimore, Maryland 21205, United States
  • Lahey Hospital and Medical Center
    Burlington, Massachusetts 01805, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Saint Louis University
    St Louis, Missouri 63104, United States
  • Hospital for Special Surgery
    New York, New York 10021, United States
  • Guilford Neurologic Associates
    Greensboro, North Carolina 27405, United States
  • Wake Forest University
    Winston-Salem, North Carolina 27157, United States
  • Providence Brain and Spine Institute
    Portland, Oregon 97213, United States
  • Oregon Health Sciences University
    Portland, Oregon 97239, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Temple University
    Philadelphia, Pennsylvania 19140, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Austin Neuromuscular Center
    Austin, Texas 78756, United States
  • Baylor Scott and White Health
    Round Rock, Texas 78665, United States
  • UT Health San Antonio
    San Antonio, Texas 78229, United States
  • The University of Utah
    Salt Lake City, Utah 84112, United States
  • University of Vermont Medical Center
    Burlington, Vermont 05405, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • Saint Luke's Rehabilitation Institute
    Spokane, Washington 99202, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Jul 2018, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2017
First posted
Jun 22, 2017
StartActual
Jul 28, 2017
Primary completionActual
Jul 27, 2018
CompletionActual
Jul 27, 2018
Last update
Aug 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03196375
Lead sponsor
Flex Pharma, Inc.
Responsible party
Sponsor
First posted
Jun 22, 2017
Start date
Jul 28, 2017
Primary completion
Jul 27, 2018
Completion
Jul 27, 2018
Last update
Aug 29, 2018

Study contacts

Bjorn Oskarsson, MD
principal investigator · Mayo Clinic Jacksonville Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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