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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Motor Neuron Disease

Intervention / Treatment
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* Drug: FLX-787-ODT (orally disintegrating tablet)
* Drug: Placebo ODT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Drug: FLX-787-ODT (orally disintegrating tablet)<br>* FLX-787-ODT taken three times daily for 28 days<br>|
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo ODT<br>* Placebo ODT taken three times daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cramp frequency | Cramp frequency measured over the 28-day treatment period | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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