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

Phase 2

Completed

• Conditions: Jet Lag Disorder
• Interventions: Drug: Placebo; Drug: Tasimelteon

• Registration Number: NCT03291041
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Results First Submitted: 2020-09-25
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Results First Posted: 2021-11-03
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, administered as oral capsule(s)
tasimelteon	Tasimelteon	tasimelteon, administered as oral capsule(s)

Primary Outcome Measures

Name	Time	Method
Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted	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 Outcome Measures

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

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Chevy Chase, Maryland, United States