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RECRUITING
NCT07087327
PHASE3

A Long-term Trial of EB-1020 in Pediatric Patients With ADHD

Sponsor: Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention- Deficit/Hyperactivity Disorder

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-09-16

Completion Date

2027-08

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DRUG

EB-1020 (Centanafadine) low dose

low dose, capsule, oral, once daily, for 52 weeks

DRUG

EB-1020 (Centanafadine) high dose

high dose, capsule, oral, once daily, for 52 weeks

Locations (1)

Hokkaido University Hospital

Sapporo, Japan