Status:
COMPLETED
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Jet Lag Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Eligibility Criteria
Inclusion
- Ability and acceptance to provide written consent
- Men or women between 18-75 years
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03291041
Start Date
July 1 2016
End Date
November 1 2017
Last Update
November 3 2021
Active Locations (3)
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1
Vanda Investigational Site
Alameda, California, United States, 94501
2
Vanda Investigational Site
Santa Monica, California, United States, 90404
3
Vanda Investigational Site
Chevy Chase, Maryland, United States, 20815