[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558959":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":22,"studyPopulation":22,"armGroups":46,"interventions":62,"overallOfficials":22,"centralContacts":88,"locations":94,"responsibleParty":177,"collaborators":22,"id":179,"slug":22,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":22,"eligibilityCriteria":184,"healthyVolunteers":180,"sex":185,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":22,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":22,"overallStatus":120,"whyStopped":22,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":22},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Pharmacokinetics: Cmax","Maximum plasma concentration of lumateperone","Day 5",{"measure":14,"description":15,"timeFrame":12},"Pharmacokinetics: Tmax","Time of maximum plasma concentration of lumateperone",{"measure":17,"description":18,"timeFrame":12},"Pharmacokinetics: AUC0-tau","Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)",[20,24,27,29,31,33,35,37],{"measure":21,"description":22,"timeFrame":23},"Percentage of patients with treatment-emergent adverse events",null,"Up to 30 days after last dose",{"measure":25,"description":22,"timeFrame":26},"Change from baseline in systolic and diastolic blood presssure","Day 6",{"measure":28,"description":22,"timeFrame":26},"Change from baseline in ECG QT interval",{"measure":30,"description":22,"timeFrame":26},"Change from baseline in hemoglobin",{"measure":32,"description":22,"timeFrame":26},"Change from baseline in white blood cell count",{"measure":34,"description":22,"timeFrame":26},"Change from baseline in aspartate aminotransferase",{"measure":36,"description":22,"timeFrame":26},"Change from baseline in alanine aminotransferase",{"measure":38,"description":39,"timeFrame":26},"Change from baseline in Abnormal Involuntary Movement Scale (AIMS)","AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4).",{"allocation":41,"interventionModel":42,"interventionModelDescription":22,"primaryPurpose":43,"observationalModel":22,"timePerspective":22,"maskingInfo":44},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":22,"whoMasked":22},"NONE",[47,54],{"label":48,"type":49,"description":50,"interventionNames":51},"Group 1 (10 to less than 13 years)","EXPERIMENTAL","Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5",[52,53],"Drug: Lumateperone 10.5 mg capsule","Drug: Lumateperone 21 mg capsule",{"label":55,"type":49,"description":56,"interventionNames":57},"Group 2 (5 to less than 10 years)","Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients",[58,59,60,61],"Drug: Lumateperone 5 mg 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3","Savannah","31405",{"type":104,"coordinates":143},[144,145],-81.09983,32.08354,{"lat":145,"lon":144},{"facility":148,"status":120,"city":149,"state":150,"zip":151,"country":101,"countryCode":102,"cosmosGeoPoint":152,"geoPoint":156,"contacts":22},"Clinical Site 4","Saint Charles","Missouri","63304",{"type":104,"coordinates":153},[154,155],-90.48123,38.78394,{"lat":155,"lon":154},{"facility":158,"status":120,"city":159,"state":160,"zip":161,"country":101,"countryCode":102,"cosmosGeoPoint":162,"geoPoint":166,"contacts":22},"Clinical Site 5","Lincoln","Nebraska","68526",{"type":104,"coordinates":163},[164,165],-96.66696,40.8,{"lat":165,"lon":164},{"facility":168,"status":120,"city":169,"state":170,"zip":171,"country":101,"countryCode":102,"cosmosGeoPoint":172,"geoPoint":176,"contacts":22},"Clinical Site 8","Everett","Washington","98201",{"type":104,"coordinates":173},[174,175],-122.20208,47.97898,{"lat":175,"lon":174},{"type":178,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100558959",false,"NCT06557902","Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder","An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Male or female patients between 5 to less than 13 years of age\n* Primary clinical diagnosis of ASD with symptoms of irritability\n* ABC-I subscale score of ≥12 at Screening\n* CGI-S score of ≥3 at Screening\n* Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening\n* Ability to swallow capsules\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than ASD\n* Reports suicidal ideation (Type 3, 4 or 5 on the Baseline\u002FScreening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and\u002For the Investigator assesses the patient to be a safety risk to him\u002Fherself or others\n* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables\n* History of a clinically significant cardiac disorder and\u002For abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \\> 460 msec at Screening\n* Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening\n* Has a history of uncontrolled\u002Fdisruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures","ALL","5 Years","12 Years",{"count":189,"type":190},26,"ESTIMATED","INTERVENTIONAL",[193],"PHASE1","Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.",[196],"Autism Spectrum Disorder","2024-08-14",{"date":199,"type":200},"2024-08-16","ACTUAL",{"date":202,"type":200},"2024-05-10",{"date":204,"type":190},"2026-07-31",{"name":5,"class":6},8]