[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronobiology-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronobiology-disorders":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100412617","phase-3-evaluating-the-effects-of-tasimelteon-vs-placebo-in-delayed-sleep-wake-phase-disorder-dswpd-100412617",false,"NCT04652882","Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)","A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)","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* Men or women between 18 - 75 years, inclusive.\n* Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg\u002Fm\\^2.\n\nExclusion Criteria:\n\n* Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months.\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":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.",[27,28,29],"Sleep Wake Disorders","Sleep Disorders, Circadian Rhythm","Chronobiology Disorders","RECRUITING","2025-11-24",{"date":33,"type":34},"2025-12-02","ACTUAL",{"date":36,"type":34},"2020-12-09",{"date":38,"type":21},"2026-06",{"name":40,"class":41},"Vanda Pharmaceuticals","INDUSTRY",17,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100569988","phase-3-evaluating-the-effects-of-tasimelteon-vs-placebo-in-delayed-sleep-wake-phase-disorder-dswpd-and-the-cry111-variant-100569988","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.",{"count":51,"type":21},60,[24],"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.",[27,28,29,55],"Gene Mutations and Other Alterations Nec","2024-11-19",{"date":58,"type":34},"2024-11-22",{"date":60,"type":34},"2024-10-08",{"date":62,"type":21},"2025-06-30",{"name":40,"class":41},1]