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A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon

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Trial Profile

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Mar 2024

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At a glance

  • Drugs Tasimelteon (Primary) ; Zopiclone
  • Indications Circadian rhythm sleep disorders; Pervasive child development disorders
  • Focus Adverse reactions
  • Sponsors Vanda Pharmaceuticals

    • Most Recent Events

    • 21 Sep 2018 New trial record
    • 12 Sep 2018 Primary endpoint has not been met. (Meaningful and significant increase in Standard Deviation of Lateral Position (SDLP), a measure of lane weaving, compared to the placebo treatment), according to a Vanda Pharmaceuticals media release.
    • 12 Sep 2018 Primary endpoint has been met. (Meaningful and significant increase in Standard Deviation of Lateral Position (SDLP), a measure of lane weaving, compared to the placebo treatment), according to a Vanda Pharmaceuticals media release.

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