VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
Phase 2
Completed
- Conditions
- Excessive Somnolence
- Registration Number
- NCT00467441
- Lead Sponsor
- Vanda Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
- Secondary Outcome Measures
Name Time Method Mood Psychomotor performance Safety and tolerability
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie VSF-173's efficacy in treating induced excessive sleepiness compared to placebo?
How does VSF-173's wakefulness-promoting activity compare to standard-of-care agents like modafinil in clinical trials?
Are there specific biomarkers associated with response to VSF-173 in healthy volunteers with sleep disorders?
What adverse event profiles have been reported for VSF-173 in phase 2 trials for excessive somnolence?
What are the competitive landscape and combination therapy strategies involving VSF-173 for sleep-related disorders?
Trial Locations
- Locations (1)
Vanda Investigational Site
🇫🇷Dijon, France
Vanda Investigational Site🇫🇷Dijon, France