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

NCT07086313 Phase 2/Phase 3 RECRUITING

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.

Details

Lead sponsor	Otsuka Pharmaceutical Co., Ltd.
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	315
Start date	2025-09-03
Completion	2027-08

Conditions

• Attention-Deficit Hyperactivity Disorder(ADHD)

Interventions

• EB-1020 (Centanafadine) low dose
• EB-1020 (Centanafadine) high dose
• Placebo

Primary outcomes

• Change from baseline in ADHD-RS-5 symptom total raw score at Week 6. — Baseline, Weeks 6
  The ADHD-RS-5 is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (never to rarely/no problem) to 3 (very often/severe problem). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.

Countries

Japan