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A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

Trial Profile

A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 09 Oct 2018

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Bipolar depression; Dyskinesias; Essential tremor; Insomnia; Major depressive disorder; Parkinson's disease; Postnatal depression; Seizures
  • Focus Therapeutic Use
  • Sponsors Sage Therapeutics
  • Most Recent Events

    • 09 Oct 2018 Results assessing safety and efficacy of 30 mg and 45 mg doses of SAGE-217, presented at the 31st Annual Congress of the European College of Neuropsychopharmacology.
    • 31 Jan 2018 Primary endpoint has been met. (Sleep efficiency, as determined by polysomnography (PSG)), as reported in a SAGE Therapeutics Media Release
    • 31 Jan 2018 Results published in the SAGE Therapeutics Media Release
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