A Phase 3 interventional study of Tasimelteon and Placebo in Jet Lag Type Insomnia, sponsored by Vanda Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
Among 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States — 146 open to participants now, 183 under way, 5 of them phase 3. Sleep Initiation and Maintenance Disorders · United States.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, this one is the 103rd largest by enrollment of the 855 interventional ones that give a count, is one of 35 that started in 2017, is one of 68 in phase 3, and was the 438th registered.
2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →146 of the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 65+ · Women only
Eight Sleep Inc. · Sites in United States
Ages 45+ · Healthy volunteers
Proactive Life Inc · Sites in United States
Ages 55+
Spectrum Clinical Research, LLC · Sites in United States
Ages 45–65 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
903 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 103 · Phase 3 77 · Phase 4 78
First in 1997; this study’s year is marked. 35 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 320 is above the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 855 interventional studies, 72 across the 48 observational. Of the 660 that completed or were terminated, 243 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
186 of 903 have an industry lead sponsor. The 10 most frequent:
Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.
Vanda Pharmaceuticals has 4 studies filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
79 of the studies in Sleep Initiation and Maintenance Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06655883Phase 3Merck Sharp & Dohme LLCA Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) | 2027-06-24 |
| NCT07336277Phase 3Emory UniversitySleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients | 2027-07 |
| NCT06953869Phase 3Vanda PharmaceuticalsEvaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia | 2027-11 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
Add all 79 to your calendar (.ics) → With an account.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tasimelteon
Drug: Placebo
Oral capsule
Oral capsule
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.
Time frame: 1 Day
Total Sleep Time
Total Sleep Time as measured by PSG.
Time frame: 1 Day
Latency to Persistent Sleep
Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
Time frame: 1 Day
Wake After Sleep Onset
The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
Time frame: 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.
Time frame: 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.
Time frame: 1 Day
| Milestone | Tasimelteon | Placebo |
|---|---|---|
| Started | 160 | 160 |
| Completed | 159 | 159 |
| Not completed | 1 | 1 |
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.
| Minutes | Placebo | Tasimelteon |
|---|---|---|
| Total Sleep Time in the First Two Thirds of the Night | 156.1 ± 80.67 | 216.4 ± 69.69 |
Total Sleep Time as measured by PSG.
| Minutes | Placebo | Tasimelteon |
|---|---|---|
| Total Sleep Time | 230.3 ± 97.39 | 315.8 ± 95.51 |
Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
| Minutes | Placebo | Tasimelteon |
|---|---|---|
| Latency to Persistent Sleep | 36.8 ± 63.56 | 21.8 ± 33.69 |
The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
| Minutes | Placebo | Tasimelteon |
|---|---|---|
| Wake After Sleep Onset | 219.1 ± 96.90 | 144.6 ± 86.73 |
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.
| Night 1 average score | Placebo | Tasimelteon |
|---|---|---|
| Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | 4.5 ± 1.86 | 4.0 ± 1.77 |
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.
| Night 1 Average Score in millimeters | Placebo | Tasimelteon |
|---|---|---|
| Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | 54.2 ± 23.46 | 60.8 ± 22.24 |
Collected over AE Data collected over the 1 Day/ 1 Night study plus a 30 day follow up period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tasimelteon | 0/160 (0%) | 1/160 (0.6%) | 8/160 (5%) |
| Placebo | 0/160 (0%) | 0/160 (0%) | 4/160 (2.5%) |
| Event | Tasimelteon | Placebo |
|---|---|---|
| Atrial FibrillationCardiac disorders | 1/160 | 0/160 |
| Event | Tasimelteon | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 8/160 | 4/160 |
| Age, Continuous(years) | Tasimelteon | Placebo | Total |
|---|---|---|---|
| Mean | 35.8 ± 11.20 | 35.9 ± 12.63 | 35.8 ± 11.92 |
| Sex: Female, Male(Participants) | Tasimelteon | Placebo | Total |
|---|---|---|---|
| Female | 86 | 81 | 167 |
| Male | 73 | 78 | 151 |
| Race/Ethnicity, Customized(participants) | Tasimelteon | Placebo | Total |
|---|---|---|---|
| White | 94 | 97 | 191 |
| Black or African American | 44 | 47 | 91 |
| Asian | 15 | 13 | 28 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| American Indian or Alaska Native | 1 | 0 | 1 |
| Other | 5 | 2 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Mar 2018, 4 months.
Results were first posted in Sep 2023, 5 years 6 months after primary completion.
Of 29 industry-sponsored phase 3 interventional studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's 4 months is below that.
Counting every sponsor, half of 42 studies reached it within 19 months; a quarter within 15 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tasimelteon
Sleep Initiation and Maintenance Disorders →