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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00467441
Enrollment
60
Registered
2007-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2007-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive Somnolence

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.

Interventions

DRUGVSF-173

Sponsors

Vanda Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Mood
Psychomotor performance
Safety and tolerability

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026