Status:
RECRUITING
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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) cond...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06926829
Start Date
June 25 2025
End Date
December 1 2027
Last Update
August 3 2025
Active Locations (1)
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1
Maynds Tower Mental Clinic
Tokyo, Japan