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

• Sponsor: Flex Pharma, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03196375
• Collaborator: (none)
• Enrollment: 54
• Locations: 35
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Motor Neuron Disease	Drug: FLX-787-ODT (orally disintegrating tablet); Drug: Placebo ODT	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 28, 2017
• Actual Primary Completion Date: Jul 27, 2018
• Actual Study Completion Date: Jul 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental	Drug: FLX-787-ODT (orally disintegrating tablet); FLX-787-ODT taken three times daily for 28 days
Placebo Comparator: Placebo Comparator	Drug: Placebo ODT; Placebo ODT taken three times daily for 28 days

Outcome Measures

Primary Outcome Measures

1. Cramp frequency [28 days]

   Cramp frequency measured over the 28-day treatment period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Honor Health Research Institute	Scottsdale	Arizona	United States	85251
2	Mayo Clinic	Scottsdale	Arizona	United States	85259
3	California Pacific Medical Center	Sacramento	California	United States	94115
4	University of California - Davis	Sacramento	California	United States	95817
5	University of California San Francisco	San Francisco	California	United States	94143
6	University of Colorado	Aurora	Colorado	United States	80045
7	Hospital for Special Care	New Britain	Connecticut	United States	06053
8	GW Medical Faculty Associates Inc.	Washington	District of Columbia	United States	20037
9	Mayo Clinic	Jacksonville	Florida	United States	32224
10	University of South Florida Health	Tampa	Florida	United States	33612
11	Emory University	Atlanta	Georgia	United States	30322
12	Indiana University Neuroscience Center	Indianapolis	Indiana	United States	46202
13	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
14	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
15	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205
16	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805
17	University of Minnesota	Minneapolis	Minnesota	United States	55455
18	Saint Louis University	Saint Louis	Missouri	United States	63104
19	Hospital for Special Surgery	New York	New York	United States	10021
20	Guilford Neurologic Associates	Greensboro	North Carolina	United States	27405
21	Wake Forest University	Winston-Salem	North Carolina	United States	27157
22	Providence Brain and Spine Institute	Portland	Oregon	United States	97213
23	Oregon Health Sciences University	Portland	Oregon	United States	97239
24	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
25	Temple University	Philadelphia	Pennsylvania	United States	19140
26	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
27	Medical University of South Carolina	Charleston	South Carolina	United States	29425
28	Austin Neuromuscular Center	Austin	Texas	United States	78756
29	Baylor Scott and White Health	Round Rock	Texas	United States	78665
30	UT Health San Antonio	San Antonio	Texas	United States	78229
31	The University of Utah	Salt Lake City	Utah	United States	84112
32	University of Vermont Medical Center	Burlington	Vermont	United States	05405
33	Virginia Commonwealth University	Richmond	Virginia	United States	23298
34	Saint Luke's Rehabilitation Institute	Spokane	Washington	United States	99202
35	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Flex Pharma, Inc.

Investigators

• Principal Investigator: Bjorn Oskarsson, MD, Mayo Clinic Jacksonville Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Flex Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT03196375
• Other Study ID Numbers: FLX-787-203
• First Posted: Jun 22, 2017
• Last Update Posted: Aug 29, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Flex Pharma, Inc.: 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
• Additional relevant MeSH terms: Muscle Cramp; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Spasm

Study Results

No Results Posted as of Aug 29, 2018