Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

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

Keywords

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 Muscle Cramp Spasm FLX-787-ODT (orally disintegrating tablet)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • California Pacific Medical Center
    Sacramento California 94115 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Flex Pharma, Inc.
ID
NCT03196375
Phase
Phase 2
Study Type
Interventional
Last Updated
June 13, 2018