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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00467441
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : November 2, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Excessive Somnolence Drug: VSF-173 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)

Secondary Outcome Measures :
  1. Mood
  2. Psychomotor performance
  3. Safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00467441

Vanda Investigational Site
Dijon, France
Sponsors and Collaborators
Vanda Pharmaceuticals
Study Director: Gunther Birznieks Vanda Pharmaceuticals Identifier: NCT00467441     History of Changes
Other Study ID Numbers: VP-VSF-173-2001
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007