A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.
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).
1 other identifier
interventional
680
3 countries
86
Brief Summary
To evaluate long-term safety exposure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2022
Typical duration for phase_3
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2022
CompletedFirst Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJanuary 27, 2026
January 1, 2026
4.2 years
March 4, 2022
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Study Arms (1)
Centanafadine Hydrochloride
EXPERIMENTAL* 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
Interventions
Capsule
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
The Center for Clinical Trials, Inc.
Saraland, Alabama, 36571, United States
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Care Access
Beverly Hills, California, 90212, United States
Proscience Research Group
Culver City, California, 90230, United States
Sun Valley Research Center, Inc.
Imperial, California, 92251, United States
Long Beach Clinical Trials Services, Inc
Long Beach, California, 90806, United States
NRC Research Institute
Orange, California, 92868, United States
SDS Clinical Trials Inc
Santa Ana, California, 92705, United States
CMB Clinical Trials
Santee, California, 92071, United States
Pacific Clinical Research Management Group LLC
Upland, California, 91786, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910, United States
Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PC
Norwich, Connecticut, 06360, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Reliable Clinical Research, LLC
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
West Broward Outpatient Site
Lauderhill, Florida, 33319, United States
Accel Research Sites - Maitland
Maitland, Florida, 32751, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Clinical Trials Solution
Miami, Florida, 33126, United States
Care Research Inc
Miami, Florida, 33130, United States
Acevedo Clinical Research Associates
Miami, Florida, 33142, United States
ABRI
Miami, Florida, 33155, United States
Ivetmar Medical Group, LLC
Miami, Florida, 33155, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Florida International Research Center
Miami, Florida, 33173, United States
Anchor Medical Research, LLC
Miami, Florida, 33176, United States
RM Medical Research, Inc.
Miami Lakes, Florida, 33014, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Apg Research, Llc
Orlando, Florida, 32803, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Space Coast Neuropsychiatric Research Institute
Palm Bay, Florida, 32905, United States
University of South Florida, Psychiatry and Behavioral Neurosciences
Tampa, Florida, 33613, United States
Neuroscience Research Institute
West Palm Beach, Florida, 33407, United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338, United States
CenExcel-iResearch, LLC
Decatur, Georgia, 30030, United States
Velocity Clinical Research Boise
Meridian, Idaho, 83642, United States
American Medical Research, Inc.
Chicago, Illinois, 60612, United States
AMR-Baber Research Inc
Naperville, Illinois, 60563, United States
Qualmedica Research
Evansville, Indiana, 47715, United States
Psychiatric Associates
Overland Park, Kansas, 66221, United States
Qualmedica Research LLC
Bowling Green, Kentucky, 42101, United States
Qualmedica Research, LLC
Owensboro, Kentucky, 42301, United States
Sisu BHR, LLC
Springfield, Massachusetts, 01103, United States
Neurobehavioral Medicine Group
Bloomfield, Michigan, 48302, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
St. Charles Psychiatric Associates / Midwest Research Group
Saint Charles, Missouri, 63304, United States
Alivation Research, LLC
Lincoln, Nebraska, 68526, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Albuquerque Neuroscience, INC
Albuquerque, New Mexico, 87109, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Manhattan Behavioral Medicine PLLC
New York, New York, 10036, United States
Onsite Clinical Solutions LLC
Charlotte, North Carolina, 28277, United States
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cincy Science
West Chester, Ohio, 45069, United States
IPS Research
Oklahoma City, Oklahoma, 73106, United States
SP Research, PLLC
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Paradigm Research Professionals LLC
Oklahoma City, Oklahoma, 73118, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
BioBehavioral Research of Austin
Austin, Texas, 78759, United States
Inquest Clinical Research Baytown Health LLC
Baytown, Texas, 77521, United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401, United States
Javara Inc.
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
InSite Clinical Research, LLC
DeSoto, Texas, 75115, United States
Allure Health at Mt. Olympus Medical Research
Friendswood, Texas, 77546, United States
Synergy Groups Medical LLC
Houston, Texas, 77087, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
AIM Trials, LLC
Plano, Texas, 75093, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
Road Runner Research, Ltd.
San Antonio, Texas, 78249, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
Velocity Clinical Research Salt Lake City
West Jordan, Utah, 84088, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
Everett, Washington, 98201, United States
Center for Pediatric Excellence
Ottawa, Ontario, K2G 1W2, Canada
Barbara Diaz Hernandez MD Research, Inc.
San Juan, 00926, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 15, 2022
Study Start
February 24, 2022
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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.