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A Long-term Trial of EB-1020 in Pediatric Patients With ADHD

RecruitingPhase 3Ages 6 Years - 17 YearsAllOtsuka Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \<Rollover participants\> * 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. * 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. \<De novo participants\> * 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. * Participants with a symptom total raw score of \>= 28 on the ADHD-RS-5 at baseline. * Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline. Exclusion Criteria: \<Rollover participants\> * Participants who have a positive pregnancy test result at baseline. * 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. * Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence. * 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. * 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. \<De novo participants\> * Participants who have a positive pregnancy test result at baseline. * Participants determined to have the following diseases based on an interview using the MINI-KID. * Tourette's disorder * Panic disorder * Conduct disorder * Psychotic disorder * Post-traumatic stress disorder * Bipolar disorder * Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria. * Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria. * 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. * 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. * Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70. * Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence. * 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/Screening version of the C-SSRS at screening. * Participants with a diagnosis of substance use disorder. * Participants who have laboratory test results at screening as follows: * Platelets\<=130,000/mm3 * Hemoglobin\<=11.2 g/dL * Neutrophils, absolute\<=1000/mm3 * AST \> 2 x ULN * ALT \> 2 x ULN * eGFR \< 45 mL/min/1.73 m2, calculated by the CKiD U25 equation * 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) * Abnormal values for both free T4 and TSH * Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.
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What it tests

  • EB-1020 (Centanafadine) low dose
  • EB-1020 (Centanafadine) high dose
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Where

1 site
Hokkaido University Hospital
Sapporo, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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