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Zopiclone

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment264

FDA Designations

No designations recorded

Clinical trial landscape

Zopiclone · 1 trial · 1 indication

Phase 3 1
NCT01369576Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep ApneaObstructive Sleep Apnea
COMPLETED264 Analytics
PHASE3COMPLETED
Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
Obstructive Sleep ApneaUnlock trial analytics

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 to 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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Frequently asked questions about Zopiclone

What is Zopiclone used for in Obstructive Sleep Apnea?

Zopiclone is being studied for use in Obstructive Sleep Apnea to improve compliance with Continuous Positive Airway Pressure (CPAP) therapy. It is a small molecule in Phase 3 clinical development, evaluated in a randomized, double-blind, placebo-controlled trial.

Who makes Zopiclone?

Zopiclone is being developed by OSR Holdings, Inc., a company traded under the ticker OSRH. The drug is currently in Phase 3 clinical development for Obstructive Sleep Apnea.

What phase is Zopiclone in?

Zopiclone is in Phase 3 clinical development. It is an investigational drug being studied for Obstructive Sleep Apnea, and it is not yet approved for this use.

What clinical trials is Zopiclone in?

Zopiclone has one completed Phase 3 clinical trial, identified as NCT01369576, titled 'Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea.' The trial enrolled 264 participants in Canada.

Is Zopiclone the same as eszopiclone?

Zopiclone is a separate drug from eszopiclone. Zopiclone is being developed by OSR Holdings, Inc. for Obstructive Sleep Apnea, while eszopiclone is a different compound. No alternative names for Zopiclone have been established in this context.