A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.

May 11, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Open-label, Long-term Trial Evaluating the Long-term Safety and Tolerability of Once Daily Centanafadine Capsules in Children and Adolescents (4 to 17 Years of Age, Inclusive) With Attention-deficit/Hyperactivity Disorder (ADHD).

To evaluate long-term safety exposure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17 years). The study will accept rollover subjects from double-blind parent trials and individuals that did not participate in one of the double-blind parent trials, may enroll as De Novo subjects after meeting all required study entry criteria. All subjects will complete a minimum of 52 weeks and may continue until all enrolled subjects within the age group the subject was in at the start of their participation in the trial (13 to 17 years; 6 to 12 years; 4 to 5 years) have had a chance to reach the Week 52 visit.

Study Type

Interventional

Enrollment (Actual)

680

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K2G 1W2
        • Center for Pediatric Excellence
  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Barbara Diaz Hernandez MD Research, Inc.
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Harmonex Neuroscience Research
      • Saraland, Alabama, United States, 36571
        • The Center for Clinical Trials, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Southwest Autism Research and Resource Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
    • California
      • Beverly Hills, California, United States, 90212
        • Care Access
      • Culver City, California, United States, 90230
        • ProScience Research Group
      • Imperial, California, United States, 92251
        • Sun Valley Research Center, Inc.
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials Services, Inc
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Santa Ana, California, United States, 92705
        • SDS Clinical Trials Inc
      • Santee, California, United States, 92071
        • CMB Clinical Trials
      • Upland, California, United States, 91786
        • Pacific Clinical Research Management Group LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PC
    • Florida
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Hialeah, Florida, United States, 33012
        • Reliable Clinical Research, LLC
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Lauderhill, Florida, United States, 33319
        • West Broward Outpatient Site
      • Maitland, Florida, United States, 32751
        • Accel Research Sites - Maitland
      • Miami, Florida, United States, 33142
        • Acevedo Clinical Research Associates
      • Miami, Florida, United States, 33173
        • Florida International Research Center
      • Miami, Florida, United States, 33155
        • Miami Clinical Research
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services, LLC
      • Miami, Florida, United States, 33176
        • Anchor Medical Research, LLC
      • Miami, Florida, United States, 33155
        • Ivetmar Medical Group, LLC
      • Miami, Florida, United States, 33126
        • Clinical Trials Solution
      • Miami, Florida, United States, 33130
        • Care Research Inc
      • Miami, Florida, United States, 33155
        • ABRI
      • Miami Lakes, Florida, United States, 33014
        • RM Medical Research, Inc.
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32803
        • Apg Research, Llc
      • Palm Bay, Florida, United States, 32905
        • Space Coast Neuropsychiatric Research Institute
      • Tampa, Florida, United States, 33613
        • University of South Florida, Psychiatry and Behavioral Neurosciences
      • West Palm Beach, Florida, United States, 33407
        • Neuroscience Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Atlanta Behavioral Research, LLC
      • Decatur, Georgia, United States, 30030
        • CenExcel-iResearch, LLC
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research Boise
    • Illinois
      • Chicago, Illinois, United States, 60612
        • American Medical Research, Inc.
      • Naperville, Illinois, United States, 60563
        • AMR-Baber Research Inc
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research
    • Kansas
      • Overland Park, Kansas, United States, 66221
        • Psychiatric Associates
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Qualmedica Research LLC
      • Owensboro, Kentucky, United States, 42301
        • Qualmedica Research, LLC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Sisu BHR, LLC
    • Michigan
      • Bloomfield, Michigan, United States, 48302
        • NeuroBehavioral Medicine Group
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates / Midwest Research Group
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Alivation Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Vector Clinical Trials
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, INC
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine PLLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • OnSite Clinical Solutions LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • West Chester, Ohio, United States, 45069
        • Cincy Science
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • IPS Research
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research Group
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research, PLLC
      • Oklahoma City, Oklahoma, United States, 73118
        • Paradigm Research Professionals LLC
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research-Providence
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions Inc.
    • Texas
      • Austin, Texas, United States, 78759
        • BioBehavioral Research of Austin
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research Baytown Health LLC
      • Bellaire, Texas, United States, 77401
        • Houston Clinical Trials, LLC
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Dallas, Texas, United States, 75230
        • Javara inc.
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research, LLC
      • Friendswood, Texas, United States, 77546
        • Allure Health at Mt. Olympus Medical Research
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
      • Houston, Texas, United States, 77087
        • Synergy Groups Medical LLC
      • Plano, Texas, United States, 75093
        • AIM Trials, LLC
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, LLC
      • San Antonio, Texas, United States, 78249
        • Road Runner Research, Ltd.
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands
    • Utah
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research Salt Lake City
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Everett, Washington, United States, 98201
        • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Rollover subjects from double-blind parent trials inclusion criteria:

  • Subjects who completed the 6-week double-blind treatment period and the 7 (+2) day follow-up in a double-blind parent trial and who, in the opinion of the investigator, could potentially benefit from centanafadine QD XR for ADHD

De novo subjects inclusion criteria:

  • Males and females aged 4 to 17 years (inclusive) at the time of informed consent/assent.
  • A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI KID.
  • A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline.
  • A score of 4 or higher on the CGI-S-ADHD at baseline.
  • Subjects aged 4 or 5 years only; has failed adequate psychotherapy or in the investigator's opinion, is severe enough to require pharmacotherapy in the absence of prior psychotherapy.

Rollover subjects from double-blind parent trials exclusion criteria:

  • Subjects who, during the double-blind parent trials, experienced, in the opinion of the investigator, poor tolerability to IMP or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with IMP.

De novo subjects exclusion criteria:

  • A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that is severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder (adolescents only), Anorexia (adolescents only), Bulimia (adolescents only), Oppositional Defiant Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), MDD with current major depressive episode, or has required treatment within the 3 months prior to screening, or in investigator's opinion, MDD may worsen or could be expected to require treatment during the course of this trial.
  • Subjects who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP.
  • A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, current suicidal behavior, Imminent risk of injury to self, active suicidal ideation, history of suicidal behavior (over the last 6 months).
  • Body weight < 13 kg
  • BMI ≥ 40 kg/m2
  • Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or are anticipated to start new treatment during the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Centanafadine Hydrochloride
  • Adolescents (13 to 17 years of age, inclusive) to receive 328.8 mg daily.
  • Children (4 to 12 years of age, inclusive) will receive weight-based doses of centanafadine ranging from 82.2 mg to 328.8 mg daily
Drug: Centanafadine Hydrochloride
Capsule
Other Names:
  • EB-1020
  • Centanafadine
  • Centanafadine XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.
Time Frame: Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Actual)

April 24, 2026

Study Completion (Actual)

April 24, 2026

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 405-201-00017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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