[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599656":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"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",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","EB-1020 (Centanafadine) low dose","low dose, capsule, oral, once daily, for 52 weeks",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"EB-1020 (Centanafadine) high dose","high dose, capsule, oral, once daily, for 52 weeks",[15],[29],{"name":30,"affiliation":5,"role":31},"Nobuhito Sanada","STUDY_DIRECTOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":11},"Drug Information Center","CONTACT","+81-3-6361-7314",[38],{"facility":39,"status":40,"city":41,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Hokkaido University Hospital","RECRUITING","Sapporo","Japan","JP",{"type":45,"coordinates":46},"Point",[47,48],141.35,43.06667,{"lat":48,"lon":47},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100599656","phase-3-a-long-term-trial-of-eb-1020-in-pediatric-patients-with-adhd-100599656",false,"NCT07087327","A Long-term Trial of EB-1020 in Pediatric Patients With ADHD","A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention- Deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n\\\u003CRollover participants\\>\n\n* Participants who completed the 6-week treatment period and 1-week follow-up period in the preceding double-blind parent trial and did not meet the criteria for discontinuation of the IMP at Week 6.\n* Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.\n\n\\\u003CDe novo participants\\>\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 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\\\u003CRollover participants\\>\n\n* Participants who have a positive pregnancy test result at baseline.\n* Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.\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 on the section of suicidal ideation or reported suicidal behavior on the since last visit version of the Columbia-Suicide Severity Rating Scale (C SSRS) in the preceding double-blind parent trial.\n* Participants who plan to use prohibited medication during the trial. Participants who used prohibited medication during the preceding double-blind parent trial should be excluded if the investigator or subinvestigator judges that there is a possibility of repeated use of prohibited medication.\n\n\\\u003CDe novo participants\\>\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. Also, 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* 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 C-SSRS at screening.\n* Participants with a diagnosis of substance use disorder.\n* Participants who have laboratory test results at screening as follows:\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 participants that the medical monitor determines that inclusion is possible based on discussion about their 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":63,"type":64},180,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in pediatric ADHD patients.",[70],"Attention-Deficit Hyperactivity Disorder(ADHD)","2025-12-16",{"date":73,"type":74},"2025-12-23","ACTUAL",{"date":76,"type":74},"2025-09-16",{"date":78,"type":64},"2027-08",{"name":5,"class":6},1]