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Zopiclone

Phase 3

Obstructive Sleep Apnea | Small molecule | Other |OSR Holdings, Inc.|Last Updated: Jul 17, 2015

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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment264
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01369576Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep ApneaPHASE3 COMPLETED 264 — — May 1, 2011Nov 1, 2014Jul 17, 20154 Canada
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Study Endpoints
Primary Endpoints
CPAP adherence
6 months
Secondary Endpoints
ESS and SAQLI scores, changes from baseline, % time of average CPAP usage over the last month/ self-estimated total sleep time (h). Residual AHI monitored, analysed for similar findings at trial closure and analysis, but is not an efficacy parameter
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORUsual sleep apnea and CPAP care Sleep apnea OSR Medical Treatment Plan©
zopicloneEXPERIMENTALSleep apnea OSR Medical Treatment plan ©
Interventions
NameTypeDescription
PlaceboDRUG3.75-7.5mg 14 doses 4 weeks
ZopicloneDRUG3.75-7.5mg 14 doses 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * MD diagnosis of obstructive sleep apnea * No previous use of CPAP * No concurrent use of hypnotic medication Exclusion Criteria: * Fatal comorbidities (i.e., life expectancy less than 6 months) * Contraindications for CPAP use * Pregnancy * Liver Failure

Countries:Canada
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