RecruitingPhase 2Phase 3NCT07086313

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

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Japan-China Joint Trial to Evaluate the Efficacy and Safety of Two Dose Levels of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention-deficit/Hyperactivity Disorder


Sponsor

Otsuka Pharmaceutical Co., Ltd.

Enrollment

315 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether EB-1020 — an investigational once-daily extended-release capsule — is effective and safe for treating attention-deficit/hyperactivity disorder (ADHD) in children. Two different doses of EB-1020 will be compared, and researchers will measure changes in ADHD symptoms and overall severity. Children with a confirmed primary ADHD diagnosis (based on DSM-5 criteria), a symptom score above a defined threshold on the ADHD Rating Scale, and a severity rating of 4 or higher on clinical assessment are eligible; children with certain other psychiatric conditions, suicidal ideation, autism spectrum disorder, or substance use disorder are excluded. Participation involves taking the study capsule once daily and attending regular clinic visits for symptom rating and safety monitoring. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEB-1020 (Centanafadine) low dose

low dose, capsule, oral, once daily, for 6 weeks

DRUGEB-1020 (Centanafadine) high dose

high dose, capsule, oral, once daily, for 6 weeks

DRUGPlacebo

Placebo, capsule, oral, once daily, for 6 weeks


Locations(1)

Hokkaido University Hospital

Sapporo, Japan

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NCT07086313


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