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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467441
First Posted: April 30, 2007
Last Update Posted: November 2, 2007
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.
Information provided by:
Vanda Pharmaceuticals
  Purpose
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 Intervention Phase
Excessive Somnolence Drug: VSF-173 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Vanda Pharmaceuticals:

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

Secondary Outcome Measures:
  • Mood
  • Psychomotor performance
  • Safety and tolerability

Estimated Enrollment: 60
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00467441


Locations
France
Vanda Investigational Site
Dijon, France
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
Study Director: Gunther Birznieks Vanda Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00467441     History of Changes
Other Study ID Numbers: VP-VSF-173-2001
First Submitted: April 26, 2007
First Posted: April 30, 2007
Last Update Posted: November 2, 2007
Last Verified: October 2007