A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Attention-Deficit Hyperactivity Disorder(ADHD)

In brief

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.

Key facts

Study ID

NCT07086313

Run by

Otsuka Pharmaceutical Co., Ltd.

People needed

315

Starts

2025-09-03

Expected to finish

2027-08-01

Last updated by the study team

2025-12-23

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.
• Participants with a symptom total raw score of>=28 (if not receiving any pharmacological treatment for ADHD) or>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening.
• Participants with a symptom total raw score of>=28 on the ADHD-RS-5 at baseline.
• Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.

You may not qualify if…

• Participants who have a positive pregnancy test result at baseline.
• Participants determined to have the following diseases based on an interview using the MINI-KID.
• Tourette's disorder
• Panic disorder
• Conduct disorder
• Psychotic disorder
• Post-traumatic stress disorder
• Bipolar disorder
• Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.
• Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.
• Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.
• Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening.
• Also, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period.
• Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70.
• 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 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
• Participants with a diagnosis of substance use disorder.
• Platelets <= 130,000/mm3
• Hemoglobin <= 11.2 g/dL
• Neutrophils, absolute <= 1000/mm3
• AST > 2 x ULN
• ALT > 2 x ULN
• eGFR < 45 mL/min/1.73 m2, calculated by the CKiD U25 equation
• CPK >= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator)
• Abnormal values for both free T4 and TSH

Where it is running

• Hokkaido University Hospital — Sapporo, Japan (enrolling)

Full record on ClinicalTrials.gov

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