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ACTIVE NOT RECRUITING

NCT05279313

PHASE3

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

To evaluate long-term safety exposure

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).

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2022-02-24

Completion Date

2026-04-30

Last Updated

2026-01-27

Healthy Volunteers

Conditions

Attention Deficit/Hyperactivity Disorder

Interventions

DRUG

Centanafadine Hydrochloride

Capsule

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.

Locations (86)

Harmonex Neuroscience Research

Dothan, Alabama, United States

The Center for Clinical Trials, Inc.

Saraland, Alabama, United States

Southwest Autism Research and Resource Center

Phoenix, Arizona, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Care Access

Beverly Hills, California, United States

Proscience Research Group

Culver City, California, United States

Sun Valley Research Center, Inc.

Imperial, California, United States

Long Beach Clinical Trials Services, Inc

Long Beach, California, United States

NRC Research Institute

Orange, California, United States

SDS Clinical Trials Inc

Santa Ana, California, United States

CMB Clinical Trials

Santee, California, United States

Pacific Clinical Research Management Group LLC

Upland, California, United States

MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PC

Norwich, Connecticut, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Reliable Clinical Research, LLC

Hialeah, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

West Broward Outpatient Site

Lauderhill, Florida, United States

Accel Research Sites - Maitland

Maitland, Florida, United States

Columbus Clinical Services, LLC

Miami, Florida, United States

Clinical Trials Solution

Miami, Florida, United States

Care Research Inc

Miami, Florida, United States

Acevedo Clinical Research Associates

Miami, Florida, United States

ABRI

Miami, Florida, United States

Ivetmar Medical Group, LLC

Miami, Florida, United States

Miami Clinical Research

Miami, Florida, United States

Florida International Research Center

Miami, Florida, United States

Anchor Medical Research, LLC

Miami, Florida, United States

RM Medical Research, Inc.

Miami Lakes, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Apg Research, Llc

Orlando, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Space Coast Neuropsychiatric Research Institute

Palm Bay, Florida, United States

University of South Florida, Psychiatry and Behavioral Neurosciences

Tampa, Florida, United States

Neuroscience Research Institute

West Palm Beach, Florida, United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States

CenExcel-iResearch, LLC

Decatur, Georgia, United States

Velocity Clinical Research Boise

Meridian, Idaho, United States

American Medical Research, Inc.

Chicago, Illinois, United States

AMR-Baber Research Inc

Naperville, Illinois, United States

Qualmedica Research

Evansville, Indiana, United States

Psychiatric Associates

Overland Park, Kansas, United States

Qualmedica Research LLC

Bowling Green, Kentucky, United States

Qualmedica Research, LLC

Owensboro, Kentucky, United States

Sisu BHR, LLC

Springfield, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

St. Charles Psychiatric Associates / Midwest Research Group

Saint Charles, Missouri, United States

Alivation Research, LLC

Lincoln, Nebraska, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Albuquerque Neuroscience, INC

Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Manhattan Behavioral Medicine PLLC

New York, New York, United States

Onsite Clinical Solutions LLC

Charlotte, North Carolina, United States

University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cincy Science

West Chester, Ohio, United States

IPS Research

Oklahoma City, Oklahoma, United States

SP Research, PLLC

Oklahoma City, Oklahoma, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Paradigm Research Professionals LLC

Oklahoma City, Oklahoma, United States

Suburban Research Associates

Media, Pennsylvania, United States

Velocity Clinical Research-Providence

East Greenwich, Rhode Island, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States

BioBehavioral Research of Austin

Austin, Texas, United States

Inquest Clinical Research Baytown Health LLC

Baytown, Texas, United States

Houston Clinical Trials, LLC

Bellaire, Texas, United States

Javara Inc.

Dallas, Texas, United States

FutureSearch Trials of Dallas

Dallas, Texas, United States

InSite Clinical Research, LLC

DeSoto, Texas, United States

Allure Health at Mt. Olympus Medical Research

Friendswood, Texas, United States

Synergy Groups Medical LLC

Houston, Texas, United States

Red Oak Psychiatry Associates, PA

Houston, Texas, United States

AIM Trials, LLC

Plano, Texas, United States

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

Road Runner Research, Ltd.

San Antonio, Texas, United States

Family Psychiatry of The Woodlands

The Woodlands, Texas, United States

Velocity Clinical Research Salt Lake City

West Jordan, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Eastside Therapeutic Resource, Inc. dba Core Clinical Research

Everett, Washington, United States

Center for Pediatric Excellence

Ottawa, Ontario, Canada

Barbara Diaz Hernandez MD Research, Inc.

San Juan, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (86)