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

Flex Pharma

Status and phase

Terminated

Phase 2

Conditions

Motor Neuron Disease

Treatments

Drug: Placebo ODT

Drug: FLX-787-ODT (orally disintegrating tablet)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03196375

FLX-787-203

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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