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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tasimelteon | Experimental | tasimelteon, administered as oral capsule(s) |
|
| Placebo | Placebo Comparator | Placebo, administered as oral capsule(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon | Drug | capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Alameda | California | 94501 | United States | ||
| Vanda Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tasimelteon | tasimelteon, administered as oral capsule(s) Tasimelteon: capsule |
| FG001 | Placebo | Placebo, administered as oral capsule(s) Placebo: capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tasimelteon | tasimelteon, administered as oral capsule(s) Tasimelteon: capsule |
| BG001 | Placebo | Placebo, administered as oral capsule(s) Placebo: capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | Standard Error | minutes | 4 days |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tasimelteon | tasimelteon, administered as oral capsule(s) Tasimelteon: capsule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 2027343400 | clinicaltrials@vandapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2018 | Aug 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C478745 | tasimelteon |
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| Drug |
capsule |
|
| 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. |
| 3 Days |
| Subjective Total Sleep Time on Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | 1 Day |
| 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. | 1 Day |
| Subjective Sleep Latency Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | 1 Day |
| Subjective Wake After Sleep Onset Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | 1 Day |
| 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. | 1 Day |
| Santa Monica |
| California |
| 90404 |
| United States |
| Vanda Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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". | Posted | Least Squares Mean | Standard Error | units on a scale | 1 Day |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | Minutes | 3 Days |
|
|
|
|
| Secondary | Subjective Total Sleep Time on Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | Posted | Least Squares Mean | Standard Error | Minutes | 1 Day |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 Day |
|
|
|
|
| Secondary | Subjective Sleep Latency Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | Posted | Least Squares Mean | Standard Error | Minutes | 1 Day |
|
|
|
|
| Secondary | Subjective Wake After Sleep Onset Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | Posted | Least Squares Mean | Standard Error | Minutes | 1 Day |
|
|
|
|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 Day |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 7 |
| 13 |
| EG001 | Placebo | Placebo, administered as oral capsule(s) Placebo: capsule | 0 | 12 | 0 | 12 | 4 | 12 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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