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
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, see Learn About Clinical Studies.

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 September 18, 2014