Status:
COMPLETED
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Jet Lag Type Insomnia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2018
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03373201
Start Date
October 16 2017
End Date
March 5 2018
Last Update
September 15 2023
Active Locations (12)
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1
Vanda Investigational Site
Little Rock, Arkansas, United States, 72211
2
Vanda Investigational Site
Alameda, California, United States, 94501
3
Vanda Investigational Site
San Diego, California, United States, 92103
4
Vanda Investigational Site
Santa Monica, California, United States, 90404