Jet Lag Disorder
Conditions
Brief summary
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Interventions
DRUGTasimelteon
capsule
DRUGPlacebo
capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability and acceptance to provide written consent * Men or women between 18-75 years * Body Mass Index of ≥ 18 and ≤ 30 kg/m2
Exclusion criteria
* History (within the 12 months prior to screening) of psychiatric disorders * 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 visit * Any other sound medical reason as determined by the clinical investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights) | 3 Days | Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. |
| Subjective Total Sleep Time on Night 3 | 1 Day | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline |
| Subjective Sleep Quality Night 3 | 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. |
| Patient Global Impression of Severity (PGI-S) Day 4 | 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. |
| Subjective Wake After Sleep Onset Night 3 | 1 Day | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline |
| Karolinska Sleepiness Scale Day 4 | 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. |
| Subjective Sleep Latency Night 3 | 1 Day | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tasimelteon tasimelteon, administered as oral capsule(s)
Tasimelteon: capsule | 13 |
| Placebo Placebo, administered as oral capsule(s)
Placebo: capsule | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Tasimelteon | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 13.47 | 49.8 years STANDARD_DEVIATION 14.54 | 48.2 years STANDARD_DEVIATION 16.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 16 Participants | 6 Participants |
| Region of Enrollment United States | 13 participants | 25 participants | 12 participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 7 / 13 | 4 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
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.
Time frame: 4 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | 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 |
| Placebo | Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted | 41.4 minutes | Standard Error 11.882 |
p-value: 0.0354ANCOVA
Secondary
Karolinska Sleepiness Scale Day 4
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.
Time frame: 1 Day
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Karolinska Sleepiness Scale Day 4 | -1.69 units on a scale | Standard Error 0.388 |
| Placebo | Karolinska Sleepiness Scale Day 4 | -0.69 units on a scale | Standard Error 0.409 |
p-value: 0.0765ANCOVA
Secondary
Patient Global Impression of Severity (PGI-S) Day 4
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.
Time frame: 1 Day
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Patient Global Impression of Severity (PGI-S) Day 4 | -0.71 units on a scale | Standard Error 0.174 |
| Placebo | Patient Global Impression of Severity (PGI-S) Day 4 | -0.07 units on a scale | Standard Error 0.183 |
p-value: 0.0168ANCOVA
Secondary
Subjective Sleep Latency Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Time frame: 1 Day
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Subjective Sleep Latency Night 3 | -20.6 Minutes | Standard Error 8.39 |
| Placebo | Subjective Sleep Latency Night 3 | 6.0 Minutes | Standard Error 8.76 |
p-value: 0.0347ANCOVA
Secondary
Subjective Sleep Quality Night 3
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.
Time frame: 1 Day
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Subjective Sleep Quality Night 3 | 1.31 units on a scale | Standard Error 0.273 |
| Placebo | Subjective Sleep Quality Night 3 | 0.36 units on a scale | Standard Error 0.29 |
p-value: 0.0198ANCOVA
Secondary
Subjective Total Sleep Time on Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Time frame: 1 Day
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Subjective Total Sleep Time on Night 3 | 111.9 Minutes | Standard Error 23.012 |
| Placebo | Subjective Total Sleep Time on Night 3 | 33.47 Minutes | Standard Error 24.555 |
p-value: 0.0225ANCOVA
Secondary
Subjective Wake After Sleep Onset Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Time frame: 1 Day
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Subjective Wake After Sleep Onset Night 3 | -81.1 Minutes | Standard Error 22.53 |
| Placebo | Subjective Wake After Sleep Onset Night 3 | -24.7 Minutes | Standard Error 24.01 |
p-value: 0.084ANCOVA
Secondary
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.
Time frame: 3 Days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tasimelteon | Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights) | 131.4 Minutes | Standard Error 35.243 |
| Placebo | Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights) | 40.9 Minutes | Standard Error 37.774 |
p-value: 0.0785ANCOVA