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

Phase 2CompletedNCT03291041

Vanda Pharmaceuticals25 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Jet Lag Disorder

Interventions

TasimelteonDRUG

capsule

PlaceboDRUG

capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Vanda Investigational Site

Alameda, California, United States

Vanda Investigational Site

Santa Monica, California, United States

Vanda Investigational Site

Chevy Chase, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 days

Secondary Outcomes

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".

Time frame: 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.

Time frame: 3 Days

Subjective Total Sleep Time on Night 3

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

Time frame: 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.

Time frame: 1 Day

Subjective Sleep Latency Night 3

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

Time frame: 1 Day

Data from ClinicalTrials.gov

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