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Completed

NCT Number: NCT03291041

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

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

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Key information

Conditions

Jet Lag Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Alameda, California, United States

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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
  • Men or women between 18-75 years
  • Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion criteria

  • History (within the 12 months prior to screening) of psychiatric disorders
  • 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 visit
  • Any other sound medical reason as determined by the clinical investigator

Treatment and study plan

tasimelteon

Drug

capsule

Placebo

Drug

capsule

Primary outcomes

  1. Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted

    Time frame: 4 days

    Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.

Secondary outcomes

  1. Patient Global Impression of Severity (PGI-S) Day 4

    Time frame: 1 Day

    Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 "Normal" to 4 "Severe".

  2. Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)

    Time frame: 3 Days

    Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.

  3. Subjective Total Sleep Time on Night 3

    Time frame: 1 Day

    Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline

  4. Subjective Sleep Quality Night 3

    Time frame: 1 Day

    Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 "Poor" to 5 "Excellent" and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality.

  5. Subjective Sleep Latency Night 3

    Time frame: 1 Day

    Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline

  6. Subjective Wake After Sleep Onset Night 3

    Time frame: 1 Day

    Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline

  7. Karolinska Sleepiness Scale Day 4

    Time frame: 1 Day

    Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2017
Registry last updated
Nov 3, 2021

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

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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.

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