[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587318":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) 164.4 mg","EXPERIMENTAL",null,[13],"Drug: EB-1020 (Centanafadine) 164.4 mg",{"label":15,"type":10,"description":11,"interventionNames":16},"EB-1020 (QD XR Capsules) 328.8 mg",[17],"Drug: EB-1020 (Centanafadine) 328.8 mg",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","EB-1020 (Centanafadine) 164.4 mg","164.4 mg, capsule, oral, once daily, for 52 weeks",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"EB-1020 (Centanafadine) 328.8 mg","328.8 mg, 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},"Maynds Tower Mental Clinic","RECRUITING","Tokyo","Japan","JP",{"type":45,"coordinates":46},"Point",[47,48],139.69171,35.6895,{"lat":48,"lon":47},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100587318","phase-3-a-long-term-trial-of-eb-1020-in-adult-patients-with-adhd-100587318",false,"NCT06926829","A Long-term Trial of EB-1020 in Adult Patients With ADHD","A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).\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\nExclusion Criteria:\n\n* Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.\n* Participants who started prohibited concomitant medications\u002Ftherapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.\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 on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or\n  * Reported suicidal behavior\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 test positive for drugs or alcohol in a urine test on baseline visit.","ALL","18 Years","55 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 patients who have completed the double-blind trial (405-102-00112) conducted in Japan",[70],"Attention Deficit Hyperactivity Disorder (ADHD)","2025-07-30",{"date":73,"type":74},"2025-08-03","ACTUAL",{"date":76,"type":74},"2025-06-25",{"date":78,"type":64},"2027-12",{"name":5,"class":6},1]