Trial | NCT03196375  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    flx-787 ...

  • Study Participants

    54
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 Started
Jul 28
2017
Primary Completion
Jul 27
2018
Study Completion
Jul 27
2018
Last Update
Aug 29
2018

Drug FLX-787-ODT (orally disintegrating tablet)

FLX-787-ODT taken three times daily for 28 days

Drug Placebo ODT

Placebo ODT taken three times daily for 28 days

Experimental Experimental

Placebo Comparator Placebo Comparator

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
No Results Posted