Trial Outcomes & Findings for Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia (NCT NCT03373201)

NCT ID: NCT03373201

Last Updated: 2023-09-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

320 participants

Primary outcome timeframe

1 Day

Results posted on

2023-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tasimelteon 20 mg tasimelteon capsule PO Daily, 1 Day	Placebo Placebo capsule PO Daily, 1 Day
Overall Study STARTED	160	160
Overall Study COMPLETED	159	159
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tasimelteon n=159 Participants Tasimelteon: Oral capsule	Placebo n=159 Participants Placebo: Oral capsule	Total n=318 Participants Total of all reporting groups
Age, Continuous	35.8 years STANDARD_DEVIATION 11.20 • n=93 Participants	35.9 years STANDARD_DEVIATION 12.63 • n=4 Participants	35.8 years STANDARD_DEVIATION 11.92 • n=27 Participants
Sex: Female, Male Female	86 Participants n=93 Participants	81 Participants n=4 Participants	167 Participants n=27 Participants
Sex: Female, Male Male	73 Participants n=93 Participants	78 Participants n=4 Participants	151 Participants n=27 Participants
Race/Ethnicity, Customized White	94 participants n=93 Participants	97 participants n=4 Participants	191 participants n=27 Participants
Race/Ethnicity, Customized Black or African American	44 participants n=93 Participants	47 participants n=4 Participants	91 participants n=27 Participants
Race/Ethnicity, Customized Asian	15 participants n=93 Participants	13 participants n=4 Participants	28 participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Other	5 participants n=93 Participants	2 participants n=4 Participants	7 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: Intent-to-Treat Population

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.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo: Oral Capsule	Tasimelteon n=159 Participants Tasimelteon: 20mg Oral Capsule
Total Sleep Time in the First Two Thirds of the Night	156.1 Minutes Standard Deviation 80.67	216.4 Minutes Standard Deviation 69.69

SECONDARY outcome

Timeframe: 1 Day

Population: Intent-to-Treat Population

Total Sleep Time as measured by PSG.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo: Oral Capsule	Tasimelteon n=159 Participants Tasimelteon: 20mg Oral Capsule
Total Sleep Time	230.3 Minutes Standard Deviation 97.39	315.8 Minutes Standard Deviation 95.51

SECONDARY outcome

Timeframe: 1 Day

Population: Intent-to-Treat Population

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

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo: Oral Capsule	Tasimelteon n=159 Participants Tasimelteon: 20mg Oral Capsule
Latency to Persistent Sleep	36.8 Minutes Standard Deviation 63.56	21.8 Minutes Standard Deviation 33.69

SECONDARY outcome

Timeframe: 1 Day

Population: Intent-to-Treat Population

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

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo: Oral Capsule	Tasimelteon n=159 Participants Tasimelteon: 20mg Oral Capsule
Wake After Sleep Onset	219.1 Minutes Standard Deviation 96.90	144.6 Minutes Standard Deviation 86.73

SECONDARY outcome

Timeframe: 1 Day

Population: Intent-to-Treat Population

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.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo: Oral Capsule	Tasimelteon n=159 Participants Tasimelteon: 20mg Oral Capsule
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)	4.5 Night 1 average score Standard Deviation 1.86	4.0 Night 1 average score Standard Deviation 1.77

SECONDARY outcome

Timeframe: 1 Day

Population: Intent-to-Treat Population

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.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Placebo: Oral Capsule	Tasimelteon n=159 Participants Tasimelteon: 20mg Oral Capsule
Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)	54.2 Night 1 Average Score in millimeters Standard Deviation 23.46	60.8 Night 1 Average Score in millimeters Standard Deviation 22.24

Adverse Events

Tasimelteon

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tasimelteon n=160 participants at risk Tasimelteon: Oral capsule	Placebo n=160 participants at risk Placebo: Oral capsule
Cardiac disorders Atrial Fibrillation	0.62% 1/160 • Number of events 1 • AE Data collected over the 1 Day/ 1 Night study plus a 30 day follow up period	0.00% 0/160 • AE Data collected over the 1 Day/ 1 Night study plus a 30 day follow up period

Other adverse events

Other adverse events
Measure	Tasimelteon n=160 participants at risk Tasimelteon: Oral capsule	Placebo n=160 participants at risk Placebo: Oral capsule
Nervous system disorders Headache	5.0% 8/160 • Number of events 8 • AE Data collected over the 1 Day/ 1 Night study plus a 30 day follow up period	2.5% 4/160 • Number of events 4 • AE Data collected over the 1 Day/ 1 Night study plus a 30 day follow up period

Additional Information

Medical Director

Vanda Pharmaceuticals

Phone: 202-734-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place