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



Status:Terminated
Conditions:Other Indications, Neurology, Metabolic
Therapuetic Areas:Neurology, Pharmacology / Toxicology, Other
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:July 28, 2017
End Date:July 27, 2018

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
35
sites
Scottsdale, Arizona 85259
Phone: 480-301-6711
1644
mi
from 43215
Scottsdale, AZ
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-727-1679
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
435
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Phone: 904-953-6912
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
675
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-5978
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
624
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
2150 Corbin Avenue
New Britain, Connecticut 06053
Phone: 860-612-6305
547
mi
from 43215
New Britain, CT
Click here to add this to my saved trials
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-647-1706
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
164
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-3724
University of Utah Research is a major component in the life of the U benefiting...
1511
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
Aurora, Colorado 80045
Phone: 303-724-4644
1158
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78703
Phone: 512-920-0140
1065
mi
from 43215
Austin, TX
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-955-8511
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
345
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
Burlington, Massachusetts 01805
Phone: 781-744-2958
637
mi
from 43215
Burlington, MA
Click here to add this to my saved trials
Burlington, Vermont 05405
Phone: 802-656-4582
591
mi
from 43215
Burlington, VT
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 842-792-9186
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
524
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Greensboro, North Carolina 27405
Phone: 336-516-9106
320
mi
from 43215
Greensboro, NC
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-0003
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
337
mi
from 43215
Hershey, PA
Click here to add this to my saved trials
355 West 16th Street
Indianapolis, Indiana 46202
Phone: 317-963-7382
167
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-356-8326
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
460
mi
from 43215
Iowa City, IA
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-945-9934
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
627
mi
from 43215
Kansas City, KS
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-805-9307
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
330
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
535 E 70th St
New York, New York 10021
(212) 606-1000
Phone: 646-797-8592
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Phone: 215-707-4171
Temple University Temple University is many things to many people. A place to pursue life's...
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Portland, Oregon 97225
Phone: 503-215-8580
2031
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Portland, Oregon 97227
Phone: 503-494-7394
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Phone: 804-827-2869
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
344
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
Round Rock, Texas 78665
Phone: 512-218-6375
?
mi
from 43215
Round Rock, TX
Click here to add this to my saved trials
2323 Sacramento Street
Sacramento, California 94115
Phone: 415-309-5178
2107
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Phone: 916-734-0968
University of California-Davis As we begin our second century, UC Davis is poised to become...
2043
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-977-4900
397
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
7703 Floyd Curl Drive
San Antonio, Texas 78229
Phone: 210-450-0524
1137
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
Phone: 415-476-9206
2109
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
10510 North 92nd Street
Scottsdale, Arizona 85251
Phone: 480-882-5564
1648
mi
from 43215
Scottsdale, AZ
Click here to add this to my saved trials
Spokane, Washington 99202
Phone: 509-473-6234
1779
mi
from 43215
Spokane, WA
Click here to add this to my saved trials
Tampa, Florida 33612
Phone: 813-974-9413
822
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Washington, District of Columbia 20037
Phone: 202-741-2745
326
mi
from 43215
Washington,
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
Phone: 336-713-8577
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials