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LY2422347

Phase 2

Sleep Initiation and Maintenance Disorders | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 26, 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 Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00259311Efficacy Study of LY2422347 to Treat InsomniaPHASE2 COMPLETED 400 — — Nov 1, 2005Nov 1, 2006Jan 26, 200722 United States
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Study Endpoints
Primary Endpoints
The primary efficacy measure will be Wakening After Sleep Onset (WASO)
Secondary Endpoints
Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
improvement of daily subjective sleep quality at endpoint
reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LY2422347DRUG -
placeboDRUG -
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Eligibility Criteria
Age Range24 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * must have been diagnosed with primary insomnia * must not be significantly overweight * must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day * must be able to read and speak in...

Countries:United States
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