[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"attention-deficit-hyperactivity-disorderadhd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:attention-deficit-hyperactivity-disorderadhd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Attention-Deficit Hyperactivity Disorder(ADHD)","RECRUITING","2025-12-16",{"date":31,"type":32},"2025-12-23","ACTUAL",{"date":34,"type":32},"2025-09-16",{"date":36,"type":21},"2027-08",{"name":38,"class":39},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":58,"locationsCount":40},"100599578","phase-2-a-trial-to-evaluate-the-efficacy-and-safety-of-eb-1020-in-pediatric-patients-with-adhd-100599578","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.",{"count":49,"type":21},315,[51,24],"PHASE2","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.",[27],{"date":31,"type":32},{"date":56,"type":32},"2025-09-03",{"date":36,"type":21},{"name":38,"class":39}]