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

This study has been completed.
Sponsor:
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00467441
First received: April 26, 2007
Last updated: October 31, 2007
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467441

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

No publications provided

ClinicalTrials.gov Identifier: NCT00467441     History of Changes
Other Study ID Numbers: VP-VSF-173-2001
Study First Received: April 26, 2007
Last Updated: October 31, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014