{"protocolSection":{"identificationModule":{"nctId":"NCT00750919","orgStudyIdInfo":{"id":"P05721"},"secondaryIdInfos":[{"id":"176003","type":"OTHER","domain":"Organon Protocol Number"},{"id":"2007-005237-10","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Merck Sharp & Dohme LLC","class":"INDUSTRY"},"briefTitle":"Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)","officialTitle":"A Twenty-six Weeks, Open-label Extension Trial to Evaluate Safety and Efficacy of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 21106"},"statusModule":{"statusVerifiedDate":"2021-01","overallStatus":"TERMINATED","whyStopped":"This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-10-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2010-03-10","type":"ACTUAL"},"completionDateStruct":{"date":"2010-03-10","type":"ACTUAL"},"studyFirstSubmitDate":"2008-09-10","studyFirstSubmitQcDate":"2008-09-10","studyFirstPostDateStruct":{"date":"2008-09-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-05-22","resultsFirstSubmitQcDate":"2014-05-22","resultsFirstPostDateStruct":{"date":"2014-06-24","type":"ESTIMATED"},"lastUpdateSubmitDate":"2021-01-19","lastUpdatePostDateStruct":{"date":"2021-02-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Merck Sharp & Dohme LLC","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657)."},"conditionsModule":{"conditions":["Sleep Initiation and Maintenance Disorders","Mental Disorders","Dyssomnias","Sleep Disorders","Sleep Disorders, Intrinsic"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":184,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Esmirtazapine","type":"EXPERIMENTAL","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.","interventionNames":["Drug: esmirtazapine"]}],"interventions":[{"type":"DRUG","name":"esmirtazapine","armGroupLabels":["Esmirtazapine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Total Sleep Time (TST)","description":"TST was defined as the time recorded for sleep diary question 6 \"how much time did you actually spend sleeping\" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.","timeFrame":"Baseline and Week 26"},{"measure":"Number of Participants Experiencing Adverse Events (AEs)","description":"An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.","timeFrame":"Up to 30 weeks"},{"measure":"Number of Participants Discontinuing Due to AEs","description":"An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.","timeFrame":"Up to 26 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Sleep Latency (SL)","description":"SL was defined as the time recorded for sleep diary question 3 \"how long did it take you to fall asleep', \" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.","timeFrame":"Baseline and Week 26"},{"measure":"Change From Baseline in Wake Time After Sleep Onset (WASO)","description":"WASO was defined as the time recorded for sleep diary question 5 \"how much time were you awake, after falling asleep initially\" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.","timeFrame":"Baseline and Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Sign written informed consent\n* Completed clinical trial 21106/P05701/MK-8265-002\n\nExclusion Criteria:\n\n* Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator\n* Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator\n* Pregnancy","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"referencesModule":{"references":[{"pmid":"32351205","type":"DERIVED","citation":"Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf","url":"http://engagezone.msd.com/ds_documentation.php"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Participants who completed P05701 (Base study NCT00631657) were eligible to enroll on P05721 (Extension study).","groups":[{"id":"FG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"184"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"126"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"58"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"9"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"Could not cooperate, unrelated to trial","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"36"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"184"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.8","spread":"11.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"111"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"73"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Total Sleep Time (TST)","description":"TST was defined as the time recorded for sleep diary question 6 \"how much time did you actually spend sleeping\" as reported by the participants using a LogPad (hand-held electronic data capture device). 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For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.","populationDescription":"The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Minutes per night","timeFrame":"Baseline and Week 26","groups":[{"id":"OG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"}]}],"classes":[{"title":"Baseline measure (n=184)","categories":[{"measurements":[{"groupId":"OG000","value":"368.1","spread":"91.5"}]}]},{"title":"Change from baseline at Week 26 (n=123)","categories":[{"measurements":[{"groupId":"OG000","value":"9.7","spread":"56.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Sleep Latency (SL)","description":"SL was defined as the time recorded for sleep diary question 3 \"how long did it take you to fall asleep', \" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.","populationDescription":"The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Minutes per night","timeFrame":"Baseline and Week 26","groups":[{"id":"OG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"}]}],"classes":[{"title":"Baseline measure (n=184)","categories":[{"measurements":[{"groupId":"OG000","value":"38.7","spread":"32.0"}]}]},{"title":"Change from baseline at Week 26 (n=123)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"39.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Wake Time After Sleep Onset (WASO)","description":"WASO was defined as the time recorded for sleep diary question 5 \"how much time were you awake, after falling asleep initially\" as reported by the participants using a LogPad (hand-held electronic data capture device). 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For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.","populationDescription":"The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Minutes per night","timeFrame":"Baseline and Week 26","groups":[{"id":"OG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"148"}]}],"classes":[{"title":"Baseline measure (n=184)","categories":[{"measurements":[{"groupId":"OG000","value":"40.0","spread":"43.5"}]}]},{"title":"Change from baseline at Week 26 (n=123)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.4","spread":"32.3"}]}]}]},{"type":"PRIMARY","title":"Number of Participants Experiencing Adverse Events (AEs)","description":"An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.","populationDescription":"The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Up to 30 weeks","groups":[{"id":"OG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"127"}]}]}]},{"type":"PRIMARY","title":"Number of Participants Discontinuing Due to AEs","description":"An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.","populationDescription":"The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Up to 26 weeks","groups":[{"id":"OG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Nonserious AEs were collected from first dispensing of study drug up to 7 days after last dose of study drug. Serious AEs were collected from first dispensing of study drug up to 30 days after last dose of study drug.","eventGroups":[{"id":"EG000","title":"Esmirtazapine","description":"Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months","seriousNumAffected":3,"seriousNumAtRisk":184,"otherNumAffected":59,"otherNumAtRisk":184}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":184}]},{"term":"Intervertebral disc degeneration","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":184}]},{"term":"Strabismus correction","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":184}]}],"otherEvents":[{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":20,"numAffected":19,"numAtRisk":184}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":11,"numAtRisk":184}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":10,"numAtRisk":184}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":10,"numAtRisk":184}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 13.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":23,"numAffected":23,"numAtRisk":184}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"This study was terminated due to the Sponsor's decision not to continue development of esmertazapine for this indication."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"LTE60","restrictiveAgreement":true},"pointOfContact":{"title":"Senior Vice President, Global Clinical Development","organization":"Merck Sharp & Dohme Corp.","email":"ClinicalTrialsDisclosure@merck.com","phone":"1-800-672-6372"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","removedCountries":["Canada","Chile","Germany","Netherlands","South Korea","Sweden","Taiwan","Thailand","United States"]},"conditionBrowseModule":{"meshes":[{"id":"D007319","term":"Sleep Initiation and Maintenance Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D020920","term":"Dyssomnias"},{"id":"D012893","term":"Sleep Wake Disorders"},{"id":"D020919","term":"Sleep Disorders, Intrinsic"}],"ancestors":[{"id":"D009422","term":"Nervous System Diseases"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078785","term":"Mirtazapine"}],"ancestors":[{"id":"D003984","term":"Dibenzazepines"},{"id":"D006575","term":"Heterocyclic Compounds, 3-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}