A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Trial Profile

A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Discontinued
Phase of Trial: Phase II

Latest Information Update: 04 Jul 2018

At a glance

  • Drugs Tasimelteon (Primary)
  • Indications Circadian rhythm sleep disorders; Jet lag
  • Focus Proof of concept; Therapeutic Use
  • Acronyms JET
  • Sponsors Vanda Pharmaceuticals
  • Most Recent Events

    • 23 May 2018 Results (n=25) presented in the Vanda Pharmaceuticals media release.
    • 23 May 2018 Status changed from active, no longer recruiting to discontinued, as reported in the Vanda Pharmaceuticals media release.
    • 23 May 2018 Due to the complexity of the study, the study was terminated before it reached the original enrolment goal of 90 patients, with only 25 patients completing both phases of the study (tasimelteon n=13, placebo n=12), according to a Vanda Pharmaceuticals media release. The company plans to file a supplemental New Drug Application for the treatment of Jet Lag Disorder with the FDA during the second half of 2018.
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