NCT06926829 A Long-term Trial of EB-1020 in Adult Patients With ADHD
| NCT ID | NCT06926829 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Condition | Attention Deficit Hyperactivity Disorder (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2025-06-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Drug Information Center
📞 +81-3-6361-7314
Nobuhito Sanada
STUDY DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT06926829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Attention Deficit Hyperactivity Disorder (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06926829 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT06926829 currently recruiting?
Yes, NCT06926829 is actively recruiting participants. Visit ClinicalTrials.gov or contact Otsuka Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT06926829 trial being conducted?
This trial is being conducted at Tokyo, Japan.
Who is sponsoring the NCT06926829 clinical trial?
NCT06926829 is sponsored by Otsuka Pharmaceutical Co., Ltd.. The principal investigator is Nobuhito Sanada at Otsuka Pharmaceutical Co., Ltd.. The trial plans to enroll 180 participants.