[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599578":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":40,"overallOfficials":53,"centralContacts":57,"locations":62,"responsibleParty":75,"collaborators":13,"id":77,"slug":13,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":13,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":13,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":13,"overallStatus":65,"whyStopped":13,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in ADHD-RS-5 symptom total raw score at Week 6.","The ADHD-RS-5 is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (never to rarely\u002Fno problem) to 3 (very often\u002Fsevere problem). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.","Baseline, Weeks 6",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,31,35],{"label":27,"type":28,"description":13,"interventionNames":29},"EB-1020(QD XR capsules) low dose","EXPERIMENTAL",[30],"Drug: EB-1020 (Centanafadine) low dose",{"label":32,"type":28,"description":13,"interventionNames":33},"EB-1020(QD XR capsules) high dose",[34],"Drug: EB-1020 (Centanafadine) high dose",{"label":36,"type":37,"description":13,"interventionNames":38},"Placebo","PLACEBO_COMPARATOR",[39],"Drug: Placebo",[41,46,50],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"DRUG","EB-1020 (Centanafadine) low dose","low dose, capsule, oral, once daily, for 6 weeks",[27],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":13},"EB-1020 (Centanafadine) high dose","high dose, capsule, oral, once daily, for 6 weeks",[32],{"type":42,"name":36,"description":51,"armGroupLabels":52,"otherNames":13},"Placebo, capsule, oral, once daily, for 6 weeks",[36],[54],{"name":55,"affiliation":5,"role":56},"Nobuhito Sanada","STUDY_DIRECTOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":13,"email":13},"Drug Information Center","CONTACT","+81-3-6361-7314",[63],{"facility":64,"status":65,"city":66,"state":13,"zip":13,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":13},"Hokkaido University Hospital","RECRUITING","Sapporo","Japan","JP",{"type":70,"coordinates":71},"Point",[72,73],141.35,43.06667,{"lat":73,"lon":72},{"type":76,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":87,"type":88},315,"ESTIMATED","INTERVENTIONAL",[91,92],"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.",[95],"Attention-Deficit Hyperactivity Disorder(ADHD)","2025-12-16",{"date":98,"type":99},"2025-12-23","ACTUAL",{"date":101,"type":99},"2025-09-03",{"date":103,"type":88},"2027-08",{"name":5,"class":6},1]