A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD

Trial Profile

A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD

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 RESET
  • 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 SET trial led to approval with the European marketing authorization for Hetlioz.
    • 05 Aug 2015 Results published in the Vanda Pharmaceuticals media release.
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