A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
1 other identifier
interventional
25
1 country
3
Brief Summary
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2016
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedResults Posted
Study results publicly available
November 3, 2021
CompletedNovember 3, 2021
October 1, 2021
1.3 years
September 8, 2016
September 25, 2020
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Patient Global Impression of Severity (PGI-S) Day 4
1 Day
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
3 Days
Subjective Total Sleep Time on Night 3
1 Day
Subjective Sleep Quality Night 3
1 Day
Subjective Sleep Latency Night 3
1 Day
- +2 more secondary outcomes
Study Arms (2)
tasimelteon
EXPERIMENTALtasimelteon, administered as oral capsule(s)
Placebo
PLACEBO COMPARATORPlacebo, administered as oral capsule(s)
Interventions
Eligibility Criteria
You may qualify if:
- Ability and acceptance to provide written consent
- Men or women between 18-75 years
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Vanda Investigational Site
Alameda, California, 94501, United States
Vanda Investigational Site
Santa Monica, California, 90404, United States
Vanda Investigational Site
Chevy Chase, Maryland, 20815, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Vanda Pharmaceuticals
- Organization
- Vanda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 25, 2017
Study Start
July 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
November 3, 2021
Results First Posted
November 3, 2021
Record last verified: 2021-10