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VSF-173

Phase 2

Excessive Somnolence | Small molecule | Other |Vanda Pharmaceuticals Inc.|Last Updated: Nov 2, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00467441VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive SleepinessPHASE2 COMPLETED 60 - -Nov 2, 20071 France
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Study Endpoints
Primary Endpoints
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
Secondary Endpoints
Mood
Psychomotor performance
Safety and tolerability
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
VSF-173DRUG -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:France
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