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

Recruiting now · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

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

Key facts

Study ID

NCT06926829

Run by

Otsuka Pharmaceutical Co., Ltd.

People needed

180

Starts

2025-06-25

Expected to finish

2027-12-01

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Maynds Tower Mental Clinic — Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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