A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon Versus Placebo in Totally Blind Subjects With N24HSWD Followed by an OLE Phase.

Trial Profile

A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon Versus Placebo in Totally Blind Subjects With N24HSWD Followed by an OLE Phase.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2015

At a glance

  • Drugs Tasimelteon (Primary)
  • Indications Circadian rhythm sleep disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms SET
  • Sponsors Vanda Pharmaceuticals
  • Most Recent Events

    • 06 Aug 2015 Results of two trials (SET and RESET) published online in the Lancet.
    • 05 Aug 2015 According to a Vanda Pharmaceuticals media release, this and RESET trial led to approval with the European marketing authorization for Hetlioz.
    • 05 Aug 2015 According to a Vanda Pharmaceuticals media release, results related to patient entrainment from this and RESET trial published in The Lancet.
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