Motor Neuron DiseasePhase 2NCT03196375
A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
A Phase 2 study testing FLX-787-ODT (orally disintegrating tablet) in people with Motor Neuron Disease, run by Flex Pharma, Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Neuron Disease
- What is being tested?
- FLX-787-ODT (orally disintegrating tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 35 sitesUnited States
- Study dates
- 28 Jul 2017to 27 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
Austin Neuromuscular Center
Austin, Texas, 78756
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
University of Vermont Medical Center
Burlington, Vermont, 05405
Medical University of South Carolina
Charleston, South Carolina, 29425
Guilford Neurologic Associates
Greensboro, North Carolina, 27405
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University Neuroscience Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Hospital for Special Care
New Britain, Connecticut, 06053
Hospital for Special Surgery
New York, New York, 10021
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Providence Brain and Spine Institute
Portland, Oregon, 97213
Oregon Health Sciences University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
Baylor Scott and White Health
Round Rock, Texas, 78665
California Pacific Medical Center
Sacramento, California, 94115
University of California - Davis
Sacramento, California, 95817
The University of Utah
Salt Lake City, Utah, 84112
UT Health San Antonio
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
Honor Health Research Institute
Scottsdale, Arizona, 85251
Mayo Clinic
Scottsdale, Arizona, 85259
Saint Luke's Rehabilitation Institute
Spokane, Washington, 99202
Saint Louis University
St Louis, Missouri, 63104
University of South Florida Health
Tampa, Florida, 33612
GW Medical Faculty Associates Inc.
Washington D.C., District of Columbia, 20037
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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 Motor Neuron Disease
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.
- Conditions
- Motor Neuron Disease
- Being tested
- FLX-787-ODT (orally disintegrating tablet), Placebo ODT
- 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
- Medical subject headings
- Motor Neuron Disease, Neurodegenerative Diseases, Nervous System Diseases, Neuromuscular Diseases, Amyotrophic Lateral Sclerosis, Muscular Atrophy, Spinal, Muscle Cramp, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLX-787-ODT (orally disintegrating tablet)Drug
FLX-787-ODT taken three times daily for 28 days
Placebo ODTDrug
Placebo ODT taken three times daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: FLX-787-ODT (orally disintegrating tablet) |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cramp frequency
Cramp frequency measured over the 28-day treatment period
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start28 Jul 2017
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Why it stopped: Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flex Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bjorn Oskarsson, MD, Principal investigator, Mayo Clinic Jacksonville Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196375
- Sponsor's protocol ID
- FLX-787-203
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2017
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Motor Neuron Disease
- ClinicalTrials.gov ID
- NCT03196375
- Acronym / sponsor ID
- FLX-787-203
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Flex Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: FLX-787-ODT (orally disintegrating tablet) |
| Placebo Comparator | Placebo comparator | Drug: Placebo ODT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLX-787-ODT (orally disintegrating tablet)FLX-787-ODT taken three times daily for 28 days | Drug | Experimental |
| Placebo ODTPlacebo ODT taken three times daily for 28 days | Drug | Placebo Comparator |
Primary outcome
Cramp frequency
Time frame: 28 days
Cramp frequency measured over the 28-day treatment period
Results and safety
The study was stopped early (reason given: Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjorn Oskarsson, MD principal investigator
Mayo Clinic Jacksonville Florida
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FLX-787-ODT (orally disintegrating tablet) in people with Motor Neuron Disease, run by Flex Pharma, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cramp frequency (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.