RecruitingPhase 3NCT06926829

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/Hyperactivity Disorder

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Enrollment

180 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria2

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 Criteria7

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.