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NCT06926829
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 180
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Location: Maynds Tower Mental Clinic Tokyo
Summary
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06926829). StuddyBuddy aggregates publicly available trial information.