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EVT 201

Phase 2

Sleep Initiation and Maintenance Disorders | Small molecule | Other |Evotec SE|Last Updated: Jan 30, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment201
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00401284Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime SleepinessPHASE2 COMPLETED 135 — — Nov 1, 2006Jul 1, 2007Jan 7, 200822 United States
NCT00380003Efficacy Study of EVT 201 to Treat InsomniaPHASE2 COMPLETED 66 — — Sep 1, 2006Apr 1, 2007Jan 30, 20085 United States
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Study Endpoints
Primary Endpoints
Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7
Total Sleep Time
Wake after sleep onset
Secondary Endpoints
Mean Multiple Sleep Latency Test at Day 8
Mean Psychomotor Vigilance Task at Day 8
Mean Karolinska Sleepiness Scale at Day 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
EVT 201DRUG -
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Diagnosis of primary insomnia according to DSM-IV * Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours * A history of sleepiness, tiredness or unintentional napping during the day...

Countries:United States
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