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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

NCT ID: NCT03291041

Last Updated: 2021-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-11-30

Brief Summary

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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Detailed Description

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Conditions

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Jet Lag Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tasimelteon

tasimelteon, administered as oral capsule(s)

Group Type EXPERIMENTAL

Tasimelteon

Intervention Type DRUG

capsule

Placebo

Placebo, administered as oral capsule(s)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule

Interventions

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Tasimelteon

capsule

Intervention Type DRUG

Placebo

capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Alameda, California, United States

Site Status

Vanda Investigational Site

Santa Monica, California, United States

Site Status

Vanda Investigational Site

Chevy Chase, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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VP-VEC-162-2102

Identifier Type: -

Identifier Source: org_study_id