A Phase 2 interventional study of FLX-787-ODT (orally disintegrating tablet) and Placebo ODT in Charcot-Marie-Tooth Disease, sponsored by Flex Pharma, Inc.. Terminated at 20 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 COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) 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 20 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.
Presence of symptoms of CMT since at least 6 months prior to Screening, and confirmed diagnosis of CMT as defined by:
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.
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.