Actively Recruiting
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2025-12-23
315
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.
CONDITIONS
Official Title
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants diagnosed with ADHD according to DSM-5 criteria, confirmed with MINI-KID interview
- Symptom total raw score of 28 or higher on ADHD-RS-5 if not on ADHD medication
- Symptom total raw score of 22 or higher on ADHD-RS-5 if on ADHD medication at screening
- Symptom total raw score of 28 or higher on ADHD-RS-5 at baseline
- Clinical Global Impression Severity score of 4 or higher for ADHD at baseline
- Age between 6 and 17 years
You will not qualify if you...
- Positive pregnancy test at baseline
- Diagnosis of Tourette's disorder, panic disorder, conduct disorder, psychotic disorder, post-traumatic stress disorder, or bipolar disorder based on MINI-KID
- Generalized anxiety disorder requiring medication
- Autism spectrum disorder diagnosis
- Personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder as primary treatment focus
- Current or recent major depressive disorder episode or treatment within past 3 months
- Intellectual disability with IQ less than 70
- Significant suicide risk or recent suicidal behavior
- Diagnosis of substance use disorder
- Platelets count 130,000/mm3 or lower
- Hemoglobin 11.2 g/dL or lower
- Absolute neutrophils 1000/mm3 or lower
- AST or ALT greater than twice the upper limit of normal
- eGFR less than 45 mL/min/1.73 m2
- CPK greater than or equal to twice the upper limit of normal unless medically cleared
- Abnormal free T4 and TSH values
- Unable to discontinue prohibited medications such as ADHD medication or antidepressants
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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