[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623575":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":22,"studyPopulation":11,"armGroups":23,"interventions":36,"overallOfficials":11,"centralContacts":45,"locations":51,"responsibleParty":198,"collaborators":11,"id":200,"slug":11,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":201,"sex":207,"minAge":208,"maxAge":11,"enrollmentInfo":209,"targetDuration":11,"studyType":212,"phases":213,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"Axsome Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time from randomization to loss of therapeutic response",null,"12 Weeks",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":19},"DOUBLE",[20,21],"PARTICIPANT","INVESTIGATOR","This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"AXS-14 (esreboxetine)","EXPERIMENTAL","* Up to 12 weeks in the open-label period;\n* Up to 12 weeks in the randomized double-blind period (if applicable)",[29],"Drug: AXS-14 (Esreboxetine)",{"label":31,"type":32,"description":33,"interventionNames":34},"Placebo","PLACEBO_COMPARATOR","• Up to 12 weeks in the randomized double-blind period (if applicable)",[35],"Drug: Placebo",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"DRUG","AXS-14 (Esreboxetine)","AXS-14 tablets taken once daily",[25],{"type":38,"name":31,"description":43,"armGroupLabels":44,"otherNames":11},"Placebo tablets taken once daily",[31],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Study 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and Country","63017",{"type":61,"coordinates":158},[159,160],-90.46345,38.61228,{"lat":160,"lon":159},{"facility":53,"status":54,"city":163,"state":164,"zip":165,"country":58,"countryCode":59,"cosmosGeoPoint":166,"geoPoint":170,"contacts":11},"Tulsa","Oklahoma","74133",{"type":61,"coordinates":167},[168,169],-95.99277,36.15398,{"lat":169,"lon":168},{"facility":53,"status":54,"city":172,"state":173,"zip":174,"country":58,"countryCode":59,"cosmosGeoPoint":175,"geoPoint":179,"contacts":11},"Charleston","South Carolina","29407",{"type":61,"coordinates":176},[177,178],-79.93275,32.77632,{"lat":178,"lon":177},{"facility":53,"status":54,"city":181,"state":182,"zip":183,"country":58,"countryCode":59,"cosmosGeoPoint":184,"geoPoint":188,"contacts":11},"Memphis","Tennessee","38119",{"type":61,"coordinates":185},[186,187],-90.04898,35.14953,{"lat":187,"lon":186},{"facility":53,"status":54,"city":190,"state":191,"zip":192,"country":58,"countryCode":59,"cosmosGeoPoint":193,"geoPoint":197,"contacts":11},"Prosper","Texas","75078",{"type":61,"coordinates":194},[195,196],-96.80111,33.23623,{"lat":196,"lon":195},{"type":199,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100623575",false,"NCT07398417","Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design","A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia","FORWARD","Inclusion Criteria:\n\n* Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.\n* Male or female, ≥18 years of age.\n* Provides written informed consent to participate in the study before conducting any study procedures.\n\nExclusion Criteria:\n\n* Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.","ALL","18 Years",{"count":210,"type":211},620,"ESTIMATED","INTERVENTIONAL",[214],"PHASE3","The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.",[217],"Fibromyalgia",[217,219,220,221,222,223,224,225,226,227],"Central Sensitization","Allodynia","Hyperalgesia","Hypersensitivity to sensory stimuli","Inhibitor of 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