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

RecruitingPhase 3Ages 18 Years - 55 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 patients who have completed the double-blind trial (405-102-00112) conducted in Japan

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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). * 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. Exclusion Criteria: * Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit. * Participants who started prohibited concomitant medications/therapies 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. * 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 on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or * Reported suicidal behavior * 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 test positive for drugs or alcohol in a urine test on baseline visit.
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What it tests

  • EB-1020 (Centanafadine) 164.4 mg
  • EB-1020 (Centanafadine) 328.8 mg
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Where

1 site
Maynds Tower Mental Clinic
Tokyo, 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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