Actively Recruiting
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2025-08-03
180
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who completed the treatment and follow-up periods in the preceding double-blind trial (405-102-00112) and did not meet discontinuation criteria for the investigational medicinal product.
- Participants without major compliance problems with the investigational product in the preceding trial.
You will not qualify if you...
- Pregnant or breastfeeding participants or those testing positive for pregnancy at baseline.
- Participants who started prohibited ADHD or other comorbidity treatments after the preceding trial's follow-up or for whom starting such treatment is considered beneficial.
- Participants with significant suicide risk, including active suicidal thoughts or reported suicidal behavior.
- Participants with serious or severe adverse events related to the investigational product in the preceding trial.
- Participants who test positive for drugs or alcohol in a urine test at baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Maynds Tower Mental Clinic
Tokyo, Japan
Actively Recruiting
Research Team
D
Drug Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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