Skip to main content
OpenTrials
Completed

NCT Number: NCT03373201

Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Jet Lag Type Insomnia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability and acceptance to provide written consent, fluent in English;
  • Healthy subjects with no medical, psychiatric or current sleep disorders;
  • Men or women between 18-75 years;
  • Body Mass Index of ≥ 18 and ≤ 30 kg/m2.

Exclusion criteria

  • Major surgery, trauma, illness or immobile for 3 or more days within the past month;
  • Pregnancy or recent pregnancy (within 6 weeks);
  • A positive test for drugs of abuse at the screening or evaluation visit.

Treatment and study plan

tasimelteon

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. Total Sleep Time in the First Two Thirds of the Night

    Time frame: 1 Day

    Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones.

Secondary outcomes

  1. Total Sleep Time

    Time frame: 1 Day

    Total Sleep Time as measured by PSG.

  2. Latency to Persistent Sleep

    Time frame: 1 Day

    Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.

  3. Wake After Sleep Onset

    Time frame: 1 Day

    The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).

  4. Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)

    Time frame: 1 Day

    A 9-point scale that measures subjective levels of fatigue by asking how sleepy subjects feel at that moment: 1 = extremely awake to 9 =extremely sleepy/fighting to stay awake.

  5. Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)

    Time frame: 1 Day

    The VAS was a self-rated scale to assess sleepiness. Participants marked along a 100 mm line to represent their current state of sleepiness, 0 being very sleepy and 100 being very alert. The VAS was administered four times following the dose administration after awakening.

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2017
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.