Long-term treatment with EB-1020 for adults with ADHD
Official title: 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
Run by Otsuka Pharmaceutical Co., Ltd. · NCT06926829 · Data updated 2026-11-12
This study is testing if a new ADHD medication called EB-1020 is safe and effective for adults who have already tried it in a previous trial over a year-long period.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06926829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who have completed a prior double-blind trial of EB-1020 without significant issues.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have significant suicidal ideation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety of long-term administration of EB-1020, a medication for ADHD, in adult patients who have previously participated in a double-blind trial. The trial will involve administering high doses of EB-1020 over a period of 52 weeks to assess its effects and safety profile. Participants must have completed the prior trial without significant issues related to compliance or treatment. The study aims to gather data on the long-term use of this medication in managing ADHD symptoms.
Why it matters
Potential benefit: If successful, this study could provide a new long-term treatment option for adults with ADHD.
How similar studies have gone: Other studies on long-term ADHD treatments have shown promise, but the specific approach of EB-1020 in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Maynds Tower Mental Clinic
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Drug Information Center
- Phone: +81-3-6361-7314
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Evaluating EB-1020 for treating adult ADHD
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.