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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00467441
• Date of registration: 26/04/2007
• Prospective Registration: No
• Primary sponsor: Vanda Pharmaceuticals
• Public title: VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
• Scientific 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
• Date of first enrolment: August 2003
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00467441
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Gunther Birznieks
• Affiliation: Vanda Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Excessive Somnolence

Intervention(s)

Drug: VSF-173

Primary Outcome(s)

Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)

Secondary Outcome(s)

Psychomotor performance

Mood

Safety and tolerability

Secondary ID(s)

VP-VSF-173-2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors