Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

Vanda Pharmaceuticals320 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

320

Conditions

Jet Lag Type Insomnia

Interventions

TasimelteonDRUG

Oral capsule

PlaceboDRUG

Oral capsule

Eligibility

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

Medical Language ↔ Plain English

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.

Locations (12)

Vanda Investigational Site

Little Rock, Arkansas, United States

Vanda Investigational Site

Alameda, California, United States

Vanda Investigational Site

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 Day

Secondary Outcomes

Total Sleep Time

Total Sleep Time as measured by PSG.

Time frame: 1 Day

Latency to Persistent Sleep

Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.

Time frame: 1 Day

Wake After Sleep Onset

The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).

Time frame: 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.

Time frame: 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.

Time frame: 1 Day

Data from ClinicalTrials.gov

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