Phase 2
N=25
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Jet Lag Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03291041 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted — 76.2; 41.4 minutes — p=0.0354
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tasimelteon (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted |
76.2; 41.4 | 0.0354 sig |
| SECONDARY Patient Global Impression of Severity (PGI-S) Day 4 |
-0.71; -0.07 | 0.0168 sig |
| SECONDARY Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights) |
131.4; 40.9 | 0.0785 |
| SECONDARY Subjective Total Sleep Time on Night 3 |
111.9; 33.47 | 0.0225 sig |
| SECONDARY Subjective Sleep Quality Night 3 |
1.31; 0.36 | 0.0198 sig |
| SECONDARY Subjective Sleep Latency Night 3 |
-20.6; 6.0 | 0.0347 sig |
| SECONDARY Subjective Wake After Sleep Onset Night 3 |
-81.1; -24.7 | 0.0840 |
| SECONDARY Karolinska Sleepiness Scale Day 4 |
-1.69; -0.69 | 0.0765 |
Summary
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03291041). 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.