[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gene-mutations-and-other-alterations-nec\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gene-mutations-and-other-alterations-nec":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Sleep Wake Disorders","Sleep Disorders, Circadian Rhythm","Chronobiology Disorders","Gene Mutations and Other Alterations Nec","RECRUITING","2024-11-19",{"date":34,"type":35},"2024-11-22","ACTUAL",{"date":37,"type":35},"2024-10-08",{"date":39,"type":21},"2025-06-30",{"name":41,"class":42},"Vanda Pharmaceuticals","INDUSTRY"]