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

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ClinicalTrials.gov Identifier: NCT00467441
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:

April 26, 2007
April 30, 2007
November 2, 2007
Not Provided
Not Provided
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Same as current
Complete list of historical versions of study NCT00467441 on ClinicalTrials.gov Archive Site
  • Mood
  • Psychomotor performance
  • Safety and tolerability
Same as current
Not Provided
Not Provided
 
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
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
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Excessive Somnolence
Drug: VSF-173
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00467441
VP-VSF-173-2001
Not Provided
Not Provided
Not Provided
Not Provided
Vanda Pharmaceuticals
Not Provided
Study Director: Gunther Birznieks Vanda Pharmaceuticals
Vanda Pharmaceuticals
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP