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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Alameda, California, United States, 94501
      • Vanda Investigational Site
    • Santa Monica, California, United States, 90404
      • Vanda Investigational Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Vanda Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tasimelteon; tasimelteon, administered as oral capsule(s)	Drug: Tasimelteon; capsule
Placebo Comparator: Placebo; Placebo, administered as oral capsule(s)	Drug: Placebo; 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 on the Night(s) Most Likely to be Disrupted	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.	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Severity (PGI-S) Day 4	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".	1 Day
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)	Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.	3 Days
Subjective Total Sleep Time on Night 3	Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline	1 Day
Subjective Sleep Quality Night 3	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.	1 Day
Subjective Sleep Latency Night 3	Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline	1 Day
Subjective Wake After Sleep Onset Night 3	Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline	1 Day
Karolinska Sleepiness Scale Day 4	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.	1 Day

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Chronobiology Disorders; Travel-Related Illness; Sleep Disorders, Circadian Rhythm; Jet Lag Syndrome
• Other Study ID Numbers: VP-VEC-162-2102