NCT07086313

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention-Deficit Hyperactivity Disorder(ADHD)

Interventions

Type	Name	Description
DRUG	EB-1020 (Centanafadine) low dose	low dose, capsule, oral, once daily, for 6 weeks
DRUG	EB-1020 (Centanafadine) high dose	high dose, capsule, oral, once daily, for 6 weeks
DRUG	Placebo	Placebo, capsule, oral, once daily, for 6 weeks

Timeline

• Start date: 2025-09-03
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-07-25
• Last updated: 2025-12-23

Locations

1 site across 1 country: Japan