Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasimelteon | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time in the First Two Thirds of the Night | 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. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | Total Sleep Time as measured by PSG. | 1 Day |
| Latency to Persistent Sleep | Length of time elapsed between lights out and onset of persistent sleep as measure by PSG. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Little Rock | Arkansas | 72211 | United States | ||
| Vanda Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32754110 | Derived | Polymeropoulos CM, Mohrman MA, Keefe MS, Brzezynski JL, Wang J, Prokosch LS, Polymeropoulos VM, Xiao C, Birznieks G, Polymeropoulos MH. Efficacy of Tasimelteon (HETLIOZ(R)) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020 Jul 9;11:611. doi: 10.3389/fneur.2020.00611. eCollection 2020. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tasimelteon | 20 mg tasimelteon capsule PO Daily, 1 Day |
| FG001 | Placebo | Placebo capsule PO Daily, 1 Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Feb 23, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral capsule |
|
| 1 Day |
| Wake After Sleep Onset | The amount of wake time during the sleep period after sleep onset (as measured by polysomnography). | 1 Day |
| Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | 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. | 1 Day |
| Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | 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. | 1 Day |
| Alameda |
| California |
| 94501 |
| United States |
| Vanda Investigational Site | San Diego | California | 92103 | United States |
| Vanda Investigational Site | Santa Monica | California | 90404 | United States |
| Vanda Investigational Site | Oakland Park | Florida | 33334 | United States |
| Vanda Investigational Site | Atlanta | Georgia | 30342 | United States |
| Vanda Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Vanda Investigational Site | St Louis | Missouri | 63141 | United States |
| Vanda Investigational Site | New York | New York | 10019 | United States |
| Vanda Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Vanda Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Vanda Investigational Site | Houston | Texas | 77063 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tasimelteon | Tasimelteon: Oral capsule |
| BG001 | Placebo | Placebo: Oral capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | 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. | Intent-to-Treat Population | Posted | Least Squares Mean | Standard Deviation | Minutes | 1 Day |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Sleep Time | Total Sleep Time as measured by PSG. | Intent-to-Treat Population | Posted | Least Squares Mean | Standard Deviation | Minutes | 1 Day |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Latency to Persistent Sleep | Length of time elapsed between lights out and onset of persistent sleep as measure by PSG. | Intent-to-Treat Population | Posted | Least Squares Mean | Standard Deviation | Minutes | 1 Day |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Wake After Sleep Onset | The amount of wake time during the sleep period after sleep onset (as measured by polysomnography). | Intent-to-Treat Population | Posted | Least Squares Mean | Standard Deviation | Minutes | 1 Day |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | 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. | Intent-to-Treat Population | Posted | Least Squares Mean | Standard Deviation | Night 1 average score | 1 Day |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | 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. | Intent-to-Treat Population | Posted | Least Squares Mean | Standard Deviation | Night 1 Average Score in millimeters | 1 Day |
|
|
AE Data collected over the 1 Day/ 1 Night study plus a 30 day follow up period
Not provided
Not provided
| 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: Oral capsule | 0 | 160 | 1 | 160 | 8 | 160 |
| EG001 | Placebo | Placebo: Oral capsule | 0 | 160 | 0 | 160 | 4 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | There was only one serious adverse event of atrial fibrillation in a subject receiving tasimelteon that was assessed as unrelated to study treatment and related to previously undiagnosed hyperthyroidism. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Vanda Pharmaceuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
| Apr 26, 2023 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C478745 | tasimelteon |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Other |
|
|
|
|
|
|
|
|
|
|
|