MedTrace Logo

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

NCT07086313 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2025-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nobuhito Sanada · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086313 on ClinicalTrials.gov