Phase 3
N=320
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Jet Lag Type Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03373201 ↗Enrolled (actual)
320
Serious AEs
0.3%
Results posted
Sep 2023
Primary outcome: Primary: Total Sleep Time in the First Two Thirds of the Night — 156.1; 216.4 Minutes — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tasimelteon (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time in the First Two Thirds of the Night |
156.1; 216.4 | <.0001 sig |
| SECONDARY Total Sleep Time |
230.3; 315.8 | <.0001 sig |
| SECONDARY Latency to Persistent Sleep |
36.8; 21.8 | <.0001 sig |
| SECONDARY Wake After Sleep Onset |
219.1; 144.6 | <.0001 sig |
| SECONDARY Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) |
4.5; 4.0 | 0.0083 sig |
| SECONDARY Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) |
54.2; 60.8 | 0.0099 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Ability and acceptance to provide written consent, fluent in English;
- Healthy subjects with no medical, psychiatric or current sleep disorders;
- Men or women between 18-75 years;
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2.
Exclusion Criteria
- 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 or evaluation visit.
Data sourced from ClinicalTrials.gov (NCT03373201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.