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.

Study Overview

• Status: Completed
• Conditions: Jet Lag Type Insomnia
• Intervention / Treatment: Drug: Placebo; Drug: Tasimelteon

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Vanda Investigational Site
  • California
    • Alameda, California, United States, 94501
      • Vanda Investigational Site
    • San Diego, California, United States, 92103
      • Vanda Investigational Site
    • Santa Monica, California, United States, 90404
      • Vanda Investigational Site
  • Florida
    • Oakland Park, Florida, United States, 33334
      • Vanda Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Vanda Investigational Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Vanda Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Vanda Investigational Site
  • New York
    • New York, New York, United States, 10019
      • Vanda Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Vanda Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Vanda Investigational Site
  • Texas
    • Houston, Texas, United States, 77063
      • Vanda Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral capsule
Experimental: Tasimelteon	Drug: Tasimelteon; Oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time in the First Two Thirds of the Night	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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time	Total Sleep Time as measured by PSG.	1 Day
Latency to Persistent Sleep	Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.	1 Day
Wake After Sleep Onset	The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).	1 Day
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)	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.	1 Day
Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)	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.	1 Day

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Publications and helpful links

General Publications

• Polymeropoulos CM, Mohrman MA, Keefe MS, Brzezynski JL, Wang J, Prokosch LS, Polymeropoulos VM, Xiao C, Birznieks G, Polymeropoulos MH. Efficacy of Tasimelteon (HETLIOZ(R)) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020 Jul 9;11:611. doi: 10.3389/fneur.2020.00611. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Chronobiology Disorders; Travel-Related Illness; Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders; Jet Lag Syndrome
• Other Study ID Numbers: VP-VEC-162-3107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No