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

Phase 3

Completed

• Conditions: Jet Lag Type Insomnia
• Interventions: Drug: Placebo; Drug: Tasimelteon

• Registration Number: NCT03373201
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-14
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Results First Submitted: 2023-01-06
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Results First Posted: 2023-09-15
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tasimelteon	Tasimelteon	-

Primary Outcome Measures

Name	Time	Method
Total Sleep Time in the First Two Thirds of the Night	1 Day	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Houston, Texas, United States