VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness

NCT ID: NCT00467441

Last Updated: 2007-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.

Detailed Description

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Conditions

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Excessive Somnolence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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VSF-173

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects with no medical, psychiatric, or current sleep disorders
* Subject must sign a written consent form

Exclusion Criteria

* Evidence of excessive daytime sleepiness
* History of sleep disorders
* Psychiatric or neurological disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Gunther Birznieks

Role: STUDY_DIRECTOR

Vanda Pharmaceuticals

Locations

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Vanda Investigational Site

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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VP-VSF-173-2001

Identifier Type: -

Identifier Source: org_study_id