Trial Outcomes & Findings for A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder (NCT NCT03291041)

Last Updated: 2021-11-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

4 days

Results posted on

2021-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Tasimelteon tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo Placebo, administered as oral capsule(s) Placebo: capsule
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule	Total n=25 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 13.47 • n=5 Participants	48.2 years STANDARD_DEVIATION 16.06 • n=7 Participants	49.8 years STANDARD_DEVIATION 14.54 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

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.

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted	76.2 minutes Standard Error 11.213	41.4 minutes Standard Error 11.882

SECONDARY outcome

Timeframe: 1 Day

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".

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Patient Global Impression of Severity (PGI-S) Day 4	-0.71 units on a scale Standard Error 0.174	-0.07 units on a scale Standard Error 0.183

SECONDARY outcome

Timeframe: 3 Days

Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)	131.4 Minutes Standard Error 35.243	40.9 Minutes Standard Error 37.774

SECONDARY outcome

Timeframe: 1 Day

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

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Subjective Total Sleep Time on Night 3	111.9 Minutes Standard Error 23.012	33.47 Minutes Standard Error 24.555

SECONDARY outcome

Timeframe: 1 Day

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.

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Subjective Sleep Quality Night 3	1.31 units on a scale Standard Error 0.273	0.36 units on a scale Standard Error 0.290

SECONDARY outcome

Timeframe: 1 Day

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

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Subjective Sleep Latency Night 3	-20.6 Minutes Standard Error 8.39	6.0 Minutes Standard Error 8.76

SECONDARY outcome

Timeframe: 1 Day

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

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Subjective Wake After Sleep Onset Night 3	-81.1 Minutes Standard Error 22.53	-24.7 Minutes Standard Error 24.01

SECONDARY outcome

Timeframe: 1 Day

Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.

Outcome measures

Outcome measures
Measure	Tasimelteon n=13 Participants tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 Participants Placebo, administered as oral capsule(s) Placebo: capsule
Karolinska Sleepiness Scale Day 4	-1.69 units on a scale Standard Error 0.388	-0.69 units on a scale Standard Error 0.409

Adverse Events

Tasimelteon

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tasimelteon n=13 participants at risk tasimelteon, administered as oral capsule(s) Tasimelteon: capsule	Placebo n=12 participants at risk Placebo, administered as oral capsule(s) Placebo: capsule
Nervous system disorders Headache	30.8% 4/13 • 15 months	33.3% 4/12 • 15 months
Gastrointestinal disorders Vomiting	15.4% 2/13 • 15 months	0.00% 0/12 • 15 months
Gastrointestinal disorders Nausea	0.00% 0/13 • 15 months	8.3% 1/12 • 15 months
Ear and labyrinth disorders Ear discomfort	7.7% 1/13 • 15 months	0.00% 0/12 • 15 months
General disorders Malaise	0.00% 0/13 • 15 months	8.3% 1/12 • 15 months
Infections and infestations Nasopharyngitis	0.00% 0/13 • 15 months	8.3% 1/12 • 15 months
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • 15 months	8.3% 1/12 • 15 months
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/13 • 15 months	8.3% 1/12 • 15 months

Additional Information

Vanda Pharmaceuticals

Phone: 2027343400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place