A Phase 2 interventional study of FLX-787-ODT (orally disintegrating tablet) and Placebo ODT in Motor Neuron Disease, sponsored by Flex Pharma, Inc.. Terminated at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Flex Pharma, Inc. · Phase 2, Interventional, and Treatment
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.
717 studies on the registry are indexed under Motor Neuron Disease; 135 are open to participants now.
This study's enrollment of 54 is above the median of 34 across 462 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Flex Pharma, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: FLX-787-ODT (orally disintegrating tablet)
Drug: Placebo ODT
FLX-787-ODT taken three times daily for 28 days
Placebo ODT taken three times daily for 28 days
Cramp frequency
Cramp frequency measured over the 28-day treatment period
Time frame: 28 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Jul 2018, 11 months.
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This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Flex Pharma, Inc.