Long-term treatment with EB-1020 for adults 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
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 |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT06926829 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who have completed a prior double-blind trial of EB-1020 without significant issues.
Not a fit: Patients who are pregnant, breastfeeding, or have significant suicidal ideation may not benefit from this study.
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 performed: Other studies on long-term ADHD treatments have shown promise, but the specific approach of EB-1020 in this context is relatively novel.
Eligibility criteria
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 this trial is running
Tokyo
- Maynds Tower Mental Clinic — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Drug Information Center
- Phone: +81-3-6361-7314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.