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Attention Deficit/Hyperactivity DisorderPhase 3NCT05279313

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

A Phase 3 study testing Centanafadine Hydrochloride in people with Attention Deficit/Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 86 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate long-term safety exposure Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Attention Deficit/Hyperactivity Disorder
What is being tested?
Centanafadine Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
86 sitesin 3 countries
Study dates
24 Feb 2022to 24 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Trial locations and contacts

86 sites in 3 countries.

86 sites in 3 countries

United States84 sites

  • Albuquerque Neuroscience, INC

    Albuquerque, New Mexico, 87109

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

  • Inquest Clinical Research Baytown Health LLC

    Baytown, Texas, 77521

  • Houston Clinical Trials, LLC

    Bellaire, Texas, 77401

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Care Access

    Beverly Hills, California, 90212

  • Neurobehavioral Medicine Group

    Bloomfield, Michigan, 48302

  • Qualmedica Research LLC

    Bowling Green, Kentucky, 42101

  • Onsite Clinical Solutions LLC

    Charlotte, North Carolina, 28277

  • American Medical Research, Inc.

    Chicago, Illinois, 60612

  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • Proscience Research Group

    Culver City, California, 90230

  • Javara Inc.

    Dallas, Texas, 75230

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231

  • CenExcel-iResearch, LLC

    Decatur, Georgia, 30030

  • InSite Clinical Research, LLC

    DeSoto, Texas, 75115

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Velocity Clinical Research-Providence

    East Greenwich, Rhode Island, 02818

  • Qualmedica Research

    Evansville, Indiana, 47715

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington, 98201

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Allure Health at Mt. Olympus Medical Research

    Friendswood, Texas, 77546

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Reliable Clinical Research, LLC

    Hialeah, Florida, 33012

  • Synergy Groups Medical LLC

    Houston, Texas, 77087

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Sun Valley Research Center, Inc.

    Imperial, California, 92251

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

  • West Broward Outpatient Site

    Lauderhill, Florida, 33319

  • Alivation Research, LLC

    Lincoln, Nebraska, 68526

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Long Beach Clinical Trials Services, Inc

    Long Beach, California, 90806

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119

  • Velocity Clinical Research Boise

    Meridian, Idaho, 83642

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125

  • Clinical Trials Solution

    Miami, Florida, 33126

  • Care Research Inc

    Miami, Florida, 33130

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142

  • ABRI

    Miami, Florida, 33155

  • Ivetmar Medical Group, LLC

    Miami, Florida, 33155

  • Miami Clinical Research

    Miami, Florida, 33155

  • Florida International Research Center

    Miami, Florida, 33173

  • Anchor Medical Research, LLC

    Miami, Florida, 33176

  • RM Medical Research, Inc.

    Miami Lakes, Florida, 33014

  • AMR-Baber Research Inc

    Naperville, Illinois, 60563

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Manhattan Behavioral Medicine PLLC

    New York, New York, 10036

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PC

    Norwich, Connecticut, 06360

  • IPS Research

    Oklahoma City, Oklahoma, 73106

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Paradigm Research Professionals LLC

    Oklahoma City, Oklahoma, 73118

  • NRC Research Institute

    Orange, California, 92868

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Apg Research, Llc

    Orlando, Florida, 32803

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Psychiatric Associates

    Overland Park, Kansas, 66221

  • Qualmedica Research, LLC

    Owensboro, Kentucky, 42301

  • Space Coast Neuropsychiatric Research Institute

    Palm Bay, Florida, 32905

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006

  • AIM Trials, LLC

    Plano, Texas, 75093

  • St. Charles Psychiatric Associates / Midwest Research Group

    Saint Charles, Missouri, 63304

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Road Runner Research, Ltd.

    San Antonio, Texas, 78249

  • SDS Clinical Trials Inc

    Santa Ana, California, 92705

  • CMB Clinical Trials

    Santee, California, 92071

  • The Center for Clinical Trials, Inc.

    Saraland, Alabama, 36571

  • Sisu BHR, LLC

    Springfield, Massachusetts, 01103

  • University of South Florida, Psychiatry and Behavioral Neurosciences

    Tampa, Florida, 33613

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas, 77381

  • Pacific Clinical Research Management Group LLC

    Upland, California, 91786

  • Cincy Science

    West Chester, Ohio, 45069

  • Velocity Clinical Research Salt Lake City

    West Jordan, Utah, 84088

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Canada1 site

  • Center for Pediatric Excellence

    Ottawa, Ontario, K2G 1W2

Other trials in Canada

Puerto Rico1 site

  • Barbara Diaz Hernandez MD Research, Inc.

    San Juan, 00926

Other trials in Puerto Rico

About this study

Official title: 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

Read the 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.

Being tested
Centanafadine Hydrochloride
Keywords
Centanafadine, ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Centanafadine HydrochlorideDrug

    Also called Centanafadine, Centanafadine XR, EB-1020

    Capsule

Study groups in NCT05279313
Study groupRoleWhat they receive
Centanafadine HydrochlorideExperimental* 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
Receives: Drug: Centanafadine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.

    Measured: Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start24 Feb 2022
  3. Primary completion24 Apr 2026
  4. Study completion24 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279313
Sponsor's protocol ID
405-201-00017
Status last verified
May 2026
First submitted
4 Mar 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Centanafadine Hydrochloride in people with Attention Deficit/Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 86 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05279313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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