Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

NCT ID: NCT00490945

Last Updated: 2014-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-03-31

Brief Summary

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The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Detailed Description

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Conditions

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Circadian Rhythm Sleep Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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VEC-162

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No medical, psychiatric, or sleep disorders
* Ability to provide written informed consent

Exclusion Criteria

* Lifetime history of night shift work
* Evidence of any sleep disorder
* Psychiatric or neurological disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Marlene Dressman, PhD

Role: STUDY_DIRECTOR

Vanda Pharmaceuticals Inc

Locations

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Vanda Investigational Site

Boston, Massachusetts, United States

Site Status

Vanda Investigational Site

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.

Reference Type DERIVED
PMID: 19054552 (View on PubMed)

Other Identifiers

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VP-VEC-162-2101

Identifier Type: -

Identifier Source: org_study_id

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