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

Launched by OTSUKA PHARMACEUTICAL CO., LTD. · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called EB-1020 to see if it is safe for adults with Attention Deficit Hyperactivity Disorder (ADHD) when taken for a long time, specifically for 52 weeks. This study is for patients who have already participated in a previous trial in Japan and completed their treatment without any serious problems.

To be eligible for this trial, participants need to have finished the earlier study without significant issues, such as not following the treatment plan. However, certain individuals cannot join, including those who are pregnant or breastfeeding, have recently started new medications for ADHD, or have serious mental health concerns such as active suicidal thoughts. Participants in this trial can expect regular check-ins and monitoring to ensure their safety while taking the medication. This study is currently recruiting participants aged between 18 and 65, and both men and women are welcome to apply.

Gender

ALL

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.