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

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 Criteria

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

Principal Investigator

Jeffrey Statland, MD

Study Contact

Jennifer Tuttle, 913-588-5703, jtuttle2@kumc.edu

Estimated Completion Date

Friday, June 1, 2018

ClinicalTrials.gov #

NCT03196375
11/05/2017