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

NCT07087327 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Attention-Deficit Hyperactivity Disorder(ADHD)

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nobuhito Sanada · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Japan

Study Locations

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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 NCT07087327 on ClinicalTrials.gov