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New daily pill for kids with ADHD shows promise in Long-Term safety trial

NCT ID NCT05279313

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the long-term safety of a daily medication called centanafadine in 680 children and teens (ages 4-17) with ADHD. The drug is a non-stimulant capsule taken once a day. Researchers tracked side effects over time to see if it is safe for extended use. The trial is already completed, and results will help doctors understand if this is a good long-term treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
centanafadine (a non-stimulant medication for ADHD)
What this could lead to
If successful, this could confirm that centanafadine is safe for long-term use in children and teens with ADHD, offering a new daily treatment option.
What could go wrong
This is an open-label trial with no placebo group, so results may be less reliable. Side effects are possible, and long-term benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

680 people

The number who actually took part.

Started

Feb 2022

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit hyperactivity disorder

Contacts and locations

Locations

  • ABRI

    Miami, Florida, 33155, United States

  • AIM Trials, LLC

    Plano, Texas, 75093, United States

  • AMR-Baber Research Inc

    Naperville, Illinois, 60563, United States

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751, United States

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142, United States

  • Albuquerque Neuroscience, INC

    Albuquerque, New Mexico, 87109, United States

  • Alivation Research, LLC

    Lincoln, Nebraska, 68526, United States

  • Allure Health at Mt. Olympus Medical Research

    Friendswood, Texas, 77546, United States

  • American Medical Research, Inc.

    Chicago, Illinois, 60612, United States

  • Anchor Medical Research, LLC

    Miami, Florida, 33176, United States

  • Apg Research, Llc

    Orlando, Florida, 32803, United States

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338, United States

  • Barbara Diaz Hernandez MD Research, Inc.

    San Juan, 00926, Puerto Rico

  • BioBehavioral Research of Austin

    Austin, Texas, 78759, United States

  • CMB Clinical Trials

    Santee, California, 92071, United States

  • Care Access

    Beverly Hills, California, 90212, United States

  • Care Research Inc

    Miami, Florida, 33130, United States

  • CenExcel-iResearch, LLC

    Decatur, Georgia, 30030, United States

  • Center for Pediatric Excellence

    Ottawa, Ontario, K2G 1W2, Canada

  • Cincy Science

    West Chester, Ohio, 45069, United States

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806, United States

  • Clinical Trials Solution

    Miami, Florida, 33126, United States

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125, United States

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116, United States

  • Direct Helpers Research Center

    Hialeah, Florida, 33012, United States

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington, 98201, United States

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas, 77381, United States

  • Florida International Research Center

    Miami, Florida, 33173, United States

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231, United States

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303, United States

  • Houston Clinical Trials, LLC

    Bellaire, Texas, 77401, United States

  • IPS Research

    Oklahoma City, Oklahoma, 73106, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • InSite Clinical Research, LLC

    DeSoto, Texas, 75115, United States

  • Inquest Clinical Research Baytown Health LLC

    Baytown, Texas, 77521, United States

  • Ivetmar Medical Group, LLC

    Miami, Florida, 33155, United States

  • Javara Inc.

    Dallas, Texas, 75230, United States

  • Long Beach Clinical Trials Services, Inc

    Long Beach, California, 90806, United States

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910, United States

  • Manhattan Behavioral Medicine PLLC

    New York, New York, 10036, United States

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PC

    Norwich, Connecticut, 06360, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • Neurobehavioral Medicine Group

    Bloomfield, Michigan, 48302, United States

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Onsite Clinical Solutions LLC

    Charlotte, North Carolina, 28277, United States

  • Pacific Clinical Research Management Group LLC

    Upland, California, 91786, United States

  • Paradigm Research Professionals LLC

    Oklahoma City, Oklahoma, 73118, United States

  • Precise Research Centers

    Flowood, Mississippi, 39232, United States

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • Proscience Research Group

    Culver City, California, 90230, United States

  • Psychiatric Associates

    Overland Park, Kansas, 66221, United States

  • Qualmedica Research

    Evansville, Indiana, 47715, United States

  • Qualmedica Research LLC

    Bowling Green, Kentucky, 42101, United States

  • Qualmedica Research, LLC

    Owensboro, Kentucky, 42301, United States

  • RM Medical Research, Inc.

    Miami Lakes, Florida, 33014, United States

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090, United States

  • Reliable Clinical Research, LLC

    Hialeah, Florida, 33012, United States

  • Road Runner Research, Ltd.

    San Antonio, Texas, 78249, United States

  • SDS Clinical Trials Inc

    Santa Ana, California, 92705, United States

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112, United States

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • Sisu BHR, LLC

    Springfield, Massachusetts, 01103, United States

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006, United States

  • Space Coast Neuropsychiatric Research Institute

    Palm Bay, Florida, 32905, United States

  • St. Charles Psychiatric Associates / Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Sun Valley Research Center, Inc.

    Imperial, California, 92251, United States

  • Synergy Groups Medical LLC

    Houston, Texas, 77087, United States

  • The Center for Clinical Trials, Inc.

    Saraland, Alabama, 36571, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

    Cincinnati, Ohio, 45219, United States

  • University of South Florida, Psychiatry and Behavioral Neurosciences

    Tampa, Florida, 33613, United States

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128, United States

  • Velocity Clinical Research Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research-Providence

    East Greenwich, Rhode Island, 02818, United States

  • West Broward Outpatient Site

    Lauderhill, Florida, 33319, United States

  • Woodland International Research Group

    Little Rock, Arkansas, 72211, United States

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