Back to resultsVSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
Primary Purpose
Excessive Somnolence
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
VSF-173
Sponsored by
About this trial
This is an interventional treatment trial for Excessive Somnolence
Eligibility Criteria
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
Sites / Locations
- Vanda Investigational Site
Outcomes
Primary Outcome Measures
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Secondary Outcome Measures
Mood
Psychomotor performance
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00467441
Brief Title
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Somnolence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VSF-173
Primary Outcome Measure Information:
Title
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Secondary Outcome Measure Information:
Title
Mood
Title
Psychomotor performance
Title
Safety and tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunther Birznieks
Organizational Affiliation
Vanda Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Vanda Investigational Site
City
Dijon
Country
France
12. IPD Sharing Statement
Learn more about this trial
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
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