[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569988":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Vanda Pharmaceuticals","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tasimelteon","EXPERIMENTAL",null,[13],"Drug: Tasimelteon",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Oral capsule",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Vanda Pharmaceuticals Inc.","CONTACT","202-734-3400","VEC162@vandapharma.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":11,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Vanda Investigational Site","RECRUITING","Çankaya","Ankara","06800","Turkey (Türkiye)",{"type":41,"coordinates":42},"Point",[43,44],32.86268,39.9179,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":11},{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100569988","phase-3-evaluating-the-effects-of-tasimelteon-vs-placebo-in-delayed-sleep-wake-phase-disorder-dswpd-and-the-cry111-variant-100569988",false,"NCT06701396","Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant","A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant","Inclusion Criteria:\n\n* Ability and acceptance to provide written informed consent.\n* A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).\n* Carrier of CRY1Δ11 variant.\n* Men or women between 18 - 75 years, inclusive.\n* Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg\u002Fm\\^2.\n\nExclusion Criteria:\n\n* Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.\n* Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.\n* A positive test for substances of abuse.\n* Current tobacco user.","ALL","18 Years","75 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65],"PHASE3","This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.",[68,69,70,71],"Sleep Wake Disorders","Sleep Disorders, Circadian Rhythm","Chronobiology Disorders","Gene Mutations and Other Alterations Nec","2024-11-19",{"date":74,"type":75},"2024-11-22","ACTUAL",{"date":77,"type":75},"2024-10-08",{"date":79,"type":62},"2025-06-30",{"name":5,"class":6},1]