NCT03196375

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Flex Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Motor Neuron Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-28
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2017-06-22
• Last updated: 2018-08-29

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study