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

Vanda Pharmaceuticals60 enrolled

Overview

The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Excessive Somnolence

Interventions

VSF-173DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vanda Investigational Site

Dijon, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

Mood

Psychomotor performance

Safety and tolerability

Data from ClinicalTrials.gov

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