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 Charcot-Marie-Tooth Disease

Trial Profile

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 Charcot-Marie-Tooth Disease

Discontinued
Phase of Trial: Phase II

Latest Information Update: 22 Jun 2018

At a glance

  • Drugs FLX 787 (Primary)
  • Indications Charcot-Marie-Tooth disease
  • Focus Therapeutic Use
  • Acronyms COMMIT
  • Sponsors Flex Pharma
  • Most Recent Events

    • 13 Jun 2018 Status changed from recruiting to discontinued, because company is ending its ongoing Phase 2 clinical trial investigations of FLX-787 in Charcot-Marie-Tooth (CMT) due to oral tolerability concerns observed , in a subset of patients being treated, with the oral disintegrating tablet formulation at 30 mg, taken three times a day, according to a Flex Pharma media release.
    • 07 Mar 2018 According to a Flex Pharma media release, the Company expects to report topline data from this study in early 2019.
    • 06 Nov 2017 According to a Flex Pharma media release, the company expects to report topline results from this trial in the third quarter of 2018.
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