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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
FLX-787-ODT taken three times daily for 28 days
Placebo ODT taken three times daily for 28 days
Honor Health Research Institute
Scottsdale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
California Pacific Medical Center
Sacramento, California, United States
University of California - Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Cramp frequency
Cramp frequency measured over the 28-day treatment period
Time frame: 28 days
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University of Colorado
Aurora, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
GW Medical Faculty Associates Inc.
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida Health
Tampa, Florida, United States
...and 25 more locations