[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599578":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"EB-1020(QD XR capsules) low dose","EXPERIMENTAL",null,[13],"Drug: EB-1020 (Centanafadine) low dose",{"label":15,"type":10,"description":11,"interventionNames":16},"EB-1020(QD XR capsules) high dose",[17],"Drug: EB-1020 (Centanafadine) high dose",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR",[22],"Drug: Placebo",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","EB-1020 (Centanafadine) low dose","low dose, capsule, oral, once daily, for 6 weeks",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"EB-1020 (Centanafadine) high dose","high dose, capsule, oral, once daily, for 6 weeks",[15],{"type":25,"name":19,"description":34,"armGroupLabels":35,"otherNames":11},"Placebo, capsule, oral, once daily, for 6 weeks",[19],[37],{"name":38,"affiliation":5,"role":39},"Nobuhito Sanada","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":11},"Drug Information Center","CONTACT","+81-3-6361-7314",[46],{"facility":47,"status":48,"city":49,"state":11,"zip":11,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":11},"Hokkaido University Hospital","RECRUITING","Sapporo","Japan","JP",{"type":53,"coordinates":54},"Point",[55,56],141.35,43.06667,{"lat":56,"lon":55},{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100599578","phase-2-a-trial-to-evaluate-the-efficacy-and-safety-of-eb-1020-in-pediatric-patients-with-adhd-100599578",false,"NCT07086313","A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD","A Phase 2\u002F3, Multicenter, Randomized, Double-blind, Placebo-controlled, Japan-China Joint Trial to Evaluate the Efficacy and Safety of Two Dose Levels of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention-deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.\n* Participants with a symptom total raw score of\\>=28 (if not receiving any pharmacological treatment for ADHD) or\\>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening.\n* Participants with a symptom total raw score of\\>=28 on the ADHD-RS-5 at baseline.\n* Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.\n\nExclusion Criteria:\n\n* Participants who have a positive pregnancy test result at baseline.\n* Participants determined to have the following diseases based on an interview using the MINI-KID.\n\n  * Tourette's disorder\n  * Panic disorder\n  * Conduct disorder\n  * Psychotic disorder\n  * Post-traumatic stress disorder\n  * Bipolar disorder\n* Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.\n* Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.\n* Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.\n* Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening.\n\nAlso, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period.\n\n* Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70.\n* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.\n\n  * Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline\u002FScreening version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.\n* Participants with a diagnosis of substance use disorder.\n\n  * Platelets \\\u003C= 130,000\u002Fmm3\n  * Hemoglobin \\\u003C= 11.2 g\u002FdL\n  * Neutrophils, absolute \\\u003C= 1000\u002Fmm3\n  * AST \\> 2 x ULN\n  * ALT \\> 2 x ULN\n  * eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2, calculated by the CKiD U25 equation\n  * CPK \\>= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator)\n  * Abnormal values for both free T4 and TSH\n* Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.","ALL","6 Years","17 Years",{"count":71,"type":72},315,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE2","PHASE3","The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.",[79],"Attention-Deficit Hyperactivity Disorder(ADHD)","2025-12-16",{"date":82,"type":83},"2025-12-23","ACTUAL",{"date":85,"type":83},"2025-09-03",{"date":87,"type":72},"2027-08",{"name":5,"class":6},1]