Actively Recruiting
A Long-term Trial of EB-1020 in Pediatric Patients With ADHD
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2025-12-23
180
Participants Needed
1
Research Sites
97 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 pediatric ADHD patients.
CONDITIONS
Official Title
A Long-term Trial of EB-1020 in Pediatric Patients With ADHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who completed the 6-week treatment and 1-week follow-up in the previous double-blind trial without criteria for stopping medication at Week 6
- Participants without major compliance or trial issues in the previous double-blind trial
- Participants with a primary ADHD diagnosis based on DSM-5 and MINI-KID, excluding other specified or unspecified ADHD
- Participants with an ADHD-RS-5 total raw score of 28 or higher at baseline
- Participants with a Clinical Global Impression Severity-ADHD score of 4 or higher at baseline
You will not qualify if you...
- Positive pregnancy test at baseline
- Serious or severe adverse events related to the study drug in the previous double-blind trial
- Significant suicide risk based on investigator judgment or positive responses on Columbia-Suicide Severity Rating Scale
- Use or planned use of prohibited medication during the trial
- Diagnoses of Tourette's disorder, panic disorder, conduct disorder, psychotic disorder, post-traumatic stress disorder, or bipolar disorder
- Generalized anxiety disorder requiring medication
- Autism spectrum disorder
- Personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder as primary treatment focus
- Major depressive disorder with current episode or recent treatment within 3 months
- Intellectual disability with IQ below 70
- Diagnosis of substance use disorder
- Laboratory abnormalities: platelets ≤130,000/mm³, hemoglobin ≤11.2 g/dL, neutrophils ≤1000/mm³, AST or ALT > 2 x upper limit normal, eGFR < 45 mL/min/1.73 m², CPK ≥ 2 x upper limit normal (unless approved by medical monitor), abnormal free T4 and TSH
- Inability to agree to stop prohibited ADHD or antidepressant medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hokkaido University Hospital
Sapporo, 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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