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

Motor Neuron Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03196375
• Other study ID #: FLX-787-203
• Status: Terminated
• Phase: Phase 2
• Start date: July 28, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: August 2018
• Source: Flex Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Motor Neuron Disease
• Muscle Cramp
• Spasm

Intervention

Drug:
• FLX-787-ODT (orally disintegrating tablet)
FLX-787-ODT taken three times daily for 28 days
• Placebo ODT
Placebo ODT taken three times daily for 28 days

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Austin Neuromuscular Center	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Guilford Neurologic Associates	Greensboro	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University Neuroscience Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Hospital for Special Care	New Britain	Connecticut
United States	Hospital for Special Surgery	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	Providence Brain and Spine Institute	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Baylor Scott and White Health	Round Rock	Texas
United States	California Pacific Medical Center	Sacramento	California
United States	University of California - Davis	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	The University of Utah	Salt Lake City	Utah
United States	UT Health San Antonio	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Honor Health Research Institute	Scottsdale	Arizona
United States	Mayo Clinic	Scottsdale	Arizona
United States	Saint Luke's Rehabilitation Institute	Spokane	Washington
United States	University of South Florida Health	Tampa	Florida
United States	GW Medical Faculty Associates Inc.	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Flex Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cramp frequency	Cramp frequency measured over the 28-day treatment period	28 days