Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
NCT ID: NCT03373201
Last Updated: 2023-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
320 participants
INTERVENTIONAL
2017-10-16
2018-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tasimelteon
Tasimelteon
Oral capsule
Placebo
Placebo
Oral capsule
Interventions
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Tasimelteon
Oral capsule
Placebo
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy or recent pregnancy (within 6 weeks);
* A positive test for drugs of abuse at the screening or evaluation visit.
18 Years
75 Years
ALL
Yes
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Little Rock, Arkansas, United States
Vanda Investigational Site
Alameda, California, United States
Vanda Investigational Site
San Diego, California, United States
Vanda Investigational Site
Santa Monica, California, United States
Vanda Investigational Site
Oakland Park, Florida, United States
Vanda Investigational Site
Atlanta, Georgia, United States
Vanda Investigational Site
Chevy Chase, Maryland, United States
Vanda Investigational Site
St Louis, Missouri, United States
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
Cincinnati, Ohio, United States
Vanda Investigational Site
Oklahoma City, Oklahoma, United States
Vanda Investigational Site
Houston, Texas, United States
Countries
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References
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Polymeropoulos CM, Mohrman MA, Keefe MS, Brzezynski JL, Wang J, Prokosch LS, Polymeropoulos VM, Xiao C, Birznieks G, Polymeropoulos MH. Efficacy of Tasimelteon (HETLIOZ(R)) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020 Jul 9;11:611. doi: 10.3389/fneur.2020.00611. eCollection 2020.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VP-VEC-162-3107
Identifier Type: -
Identifier Source: org_study_id
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