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

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

Quick Info:

Status:
This study has been terminated
Estimated Enrollment:
120
Phase:
2
Treatment Type:
Drug: FLX-787-ODT
Trial Type:
Randomized parallel assignment
Sponsor:
Flex Pharma, Inc.
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
N/A
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

6/18/2018Flex Pharma announced via press release discontinuation of study due to tolerability concerns.
3/23/2018Locations updated
1/30/2018Locations updated
12/18/2017Locations updated
12/1/2017Locations updated
11/7/2017Locations and recruitment status updated
10/26/2017Locations and recruitment status updated
10/16/2017Recruitment status updated
9/29/2017Locations updated
9/11/2017Location and recruitment updated
8/10/2017Recruitment status updated
7/10/2017Trial added

Locations:

California Pacific Medical Center, Sacramento, 94115
GW Medical Faculty Associates Inc., Washington, 20037
Guilford Neurologic Associates, Greensboro, 27405
Honor Health Research Institute, Scottsdale, 85251
Hospital for Special Care, New Britain, 06053
Hospital for Special Surgery, New York, 10021
Indiana University Neuroscience Center, Indianapolis, 46202
Johns Hopkins Hospital, Baltimore, 21205
Lahey Hospital and Medical Center, Burlington, 01805
Mayo Clinic, Jacksonville, 32224
Mayo Clinic, Scottsdale, 85259
Medical College of Wisconsin, Milwaukee, 53226
Penn State Milton S. Hershey Medical Center, Hershey, 17033
Providence Brain and Spine Institute, Portland, 97213
Saint Louis University, Saint Louis, 63104
Saint Luke's Rehabilitation Institute, Spokane, 99202
Temple University, Philadelphia, 19140
The University of Utah, Salt Lake City, 84112
UT Health San Antonio, San Antonio, 78229
University of Colorado, Aurora, 80045
University of Iowa Hospitals and Clinics, Iowa City, 52242
University of Kansas Medical Center, Kansas City, 66160
University of Pittsburgh, Pittsburgh, 15213
University of South Florida Health, Tampa, 33612
University of Vermont Medical Center, Burlington, 05405
Wake Forest University, Winston-Salem, 27157
University of Minnesota, Minneapolis, 55455
Medical University of South Carolina, Charleston, 29425
University of California - Davis, Sacramento, 95817
University of California San Francisco, San Francisco, 94143
Virginia Commonwealth University, Richmond, 23298

Other Information:

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.
Eligibility: 18 years and older, all genders, not accepting healthy volunteers
Details: This study was stopped by the Sponsor in June 2018 due to side effect issues. They believe those issues were related to the dose of the substance used.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 6/20/2017
ClinicalTrials.gov ID: NCT03196375
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov