NCT00467441CompletedPhase 2
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vanda Pharmaceuticals
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Secondary Outcomes
- Mood
- Psychomotor performance
- Safety and tolerability
Investigators
Study Sites (1)
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