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

NCT03196375 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-08-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Flex Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Bjorn Oskarsson, MD · Mayo Clinic Jacksonville Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2018-07-27
Completion
2018-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03196375 on ClinicalTrials.gov