Trial · NCT03373201

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

NCT03373201, Phase 3, Completed, Vanda Pharmaceuticals; results first posted 2023-09-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia. Trials, record NCT03373201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03373201

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
NCT number: NCT03373201
Status: Completed
Phases: Phase 3
Enrollment: 320 participants, actual
Lead sponsor: Vanda Pharmaceuticals
Conditions: Jet Lag Type Insomnia
Interventions: Tasimelteon, Placebo
First posted: 2017-12-14
Last updated: 2023-09-15
Results first posted: 2023-09-15

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Total Sleep Time	1 Day	Total Sleep Time as measured by PSG.
Secondary	Latency to Persistent Sleep	1 Day	Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
Secondary	Wake After Sleep Onset	1 Day	The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Sleep Time in the First Two Thirds of the Night	1 Day	Intent-to-Treat Population	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Total Sleep Time	1 Day	Intent-to-Treat Population	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Latency to Persistent Sleep	1 Day	Intent-to-Treat Population	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Wake After Sleep Onset	1 Day	Intent-to-Treat Population	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)	1 Day	Intent-to-Treat Population	Night 1 average score	LEAST_SQUARES_MEAN
SECONDARY	Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)	1 Day	Intent-to-Treat Population	Night 1 Average Score in millimeters	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Sleep Time in the First Two Thirds of the Night	Placebo	156.1	Standard Deviation 80.67	Minutes
Total Sleep Time in the First Two Thirds of the Night	Tasimelteon	216.4	Standard Deviation 69.69	Minutes
Total Sleep Time	Placebo	230.3	Standard Deviation 97.39	Minutes
Total Sleep Time	Tasimelteon	315.8	Standard Deviation 95.51	Minutes
Latency to Persistent Sleep	Placebo	36.8	Standard Deviation 63.56	Minutes
Latency to Persistent Sleep	Tasimelteon	21.8	Standard Deviation 33.69	Minutes
Wake After Sleep Onset	Placebo	219.1	Standard Deviation 96.90	Minutes
Wake After Sleep Onset	Tasimelteon	144.6	Standard Deviation 86.73	Minutes
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)	Placebo	4.5	Standard Deviation 1.86	Night 1 average score
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)	Tasimelteon	4.0	Standard Deviation 1.77	Night 1 average score

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tasimelteon	160
Overall Study	STARTED	Placebo	160
Overall Study	COMPLETED	Tasimelteon	159
Overall Study	COMPLETED	Placebo	159
Overall Study	NOT COMPLETED	Tasimelteon	1
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Tasimelteon	8	160	8
other	Headache	Nervous system disorders	Placebo	4	160	4
serious	Atrial Fibrillation	Cardiac disorders	Tasimelteon	1	160	1
serious	Atrial Fibrillation	Cardiac disorders	Placebo	0	160	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tasimelteon	0	160
Total, all-cause mortality	Placebo	0	160
Total, other adverse events	Tasimelteon	8	160
Total, other adverse events	Placebo	4	160
Total, serious adverse events	Tasimelteon	1	160
Total, serious adverse events	Placebo	0	160

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32754110	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tasimelteon vs Placebo: deaths from any cause	Trial comparisons
Tasimelteon vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03373201

GET https://conductscience.org/api/trials/v1/NCT03373201/registered

API reference For AI assistants