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CompletedPhase 3

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

Key facts

Who runs it
Otsuka Pharmaceutical Development & Commercialization, Inc.
Where
Albuquerque, Atlanta, Austin, Baytown, Bellaire, Bellevue, Beverly Hills, Bloomfield, Bowling Green, Charlotte, Chicago, Cincinnati, Cleveland, Colorado Springs, Culver City, Dallas, Decatur, DeSoto, Dothan, East Greenwich, Evansville, Everett, Flowood, Friendswood, Gainesville, Hialeah, Houston, Imperial, Jacksonville, Las Vegas, Lauderhill, Lincoln, Little Rock, Long Beach, Maitland, Media, Memphis, Meridian, Miami, Miami Lakes, Naperville, New York, North Charleston, Norwich, Oklahoma City, Orange, Orange City, Orlando, Overland Park, Owensboro, Palm Bay, Phoenix, Plano, Saint Charles, San Antonio, Santa Ana, Santee, Saraland, Springfield, Tampa, The Woodlands, Upland, West Chester, West Jordan, and West Palm Beach, United StatesSee the 83 sitesAlso in 2 other countries, 2 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
680 people enrolled
Started
24 Feb 2022
Ended
24 Apr 2026
Type of study
Interventional
Treatments tested
  • Centanafadine Hydrochloride
Record updated
14 May 2026

Who can take part

Age
4 years to 18 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Other criteria

  • 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

Where in United States

Also in 2 other countries, 2 sites

  • Albuquerque Neuroscience Inc.Albuquerque, United States
  • Atlanta Behavioral Research, LLCAtlanta, United States
  • BioBehavioral Research of AustinAustin, United States
  • Inquest Clinical Research Baytown Health LLCBaytown, United States
  • Houston Clinical Trials, LLCBellaire, United States
  • Northwest Clinical Research CenterBellevue, United States
  • Care AccessBeverly Hills, United States
  • Neurobehavioral Medicine GroupBloomfield, United States
  • Qualmedica Research, LLCBowling Green, United States
  • Onsite Clinical Solutions, LLCCharlotte, United States
  • American Medical Research, Inc.Chicago, United States
  • University of Cincinnati Department of Psychiatry and Behavioral NeuroscienceCincinnati, United States
  • University Hospitals Cleveland Medical Center*Cleveland, United States
  • MCB Clinical Research CentersColorado Springs, United States
  • ProScience Research GroupCulver City, United States
  • FutureSearch Trials of DallasDallas, United States
  • Javara Inc.Dallas, United States
  • CenExcel iResearch LLCDecatur, United States
  • InSite Clinical Research, LLCDeSoto, United States
  • Harmonex Neuroscience ResearchDothan, United States
  • Velocity Clinical Research, ProvidenceEast Greenwich, United States
  • Qualmedica ResearchEvansville, United States
  • Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchEverett, United States
  • Precise Research CentersFlowood, United States
  • Allure Health at Mt. Olympus Medical ResearchFriendswood, United States
  • Sarkis Clinical TrialsGainesville, United States
  • Direct Helpers Research CenterHialeah, United States
  • Reliable Clinical Research LLCHialeah, United States
  • Red Oak Psychiatry Associates, PAHouston, United States
  • Synergy Groups Medical LLCHouston, United States
  • Sun Valley Research Center, Inc.Imperial, United States
  • Clinical NeuroScience Solutions IncJacksonville, United States
  • Vector Clinical TrialsLas Vegas, United States
  • Lauderhill, FloridaHospital not named in the registry
  • Alivation Research, LLCLincoln, United States
  • Preferred Research Partners, IncLittle Rock, United States
  • Woodland International Research GroupLittle Rock, United States
  • Long Beach Clinical Trials Services, IncLong Beach, United States
  • Accel Research Sites - MaitlandMaitland, United States
  • Suburban Research AssociatesMedia, United States
  • Clinical Neuroscience Solutions, Inc.Memphis, United States
  • Velocity Clinical Research, BoiseMeridian, United States
  • ABRIMiami, United States
  • Acevedo Clinical Research AssociatesMiami, United States
  • Anchor Medical Research LLCMiami, United States
  • Care Research IncMiami, United States
  • Clinical Trials SolutionMiami, United States
  • Columbus Clinical Services LLCMiami, United States
  • Florida International Research CenterMiami, United States
  • Ivetmar Medical Group, LLCMiami, United States
  • Miami Clinical ResearchMiami, United States
  • RM Medical Research IncMiami Lakes, United States
  • AMR-Baber Research IncNaperville, United States
  • Icahn School of Medicine at Mount SinaiNew York, United States
  • Manhattan Behavioral Medicine PLLCNew York, United States
  • Coastal Carolina Research CenterNorth Charleston, United States
  • Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PCNorwich, United States
  • Cutting Edge Research GroupOklahoma City, United States
  • IPS ResearchOklahoma City, United States
  • Paradigm Research Professionals, LLCOklahoma City, United States
  • SP Research PLLCOklahoma City, United States
  • NRC Research InstituteOrange, United States
  • Medical Research Group of Central FloridaOrange City, United States
  • APG Research, LLCOrlando, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • Psychiatric AssociatesOverland Park, United States
  • Qualmedica Research, LLCOwensboro, United States
  • Space Coast Neuropsychiatric Research InstitutePalm Bay, United States
  • Southwest Autism Research and Resource CenterPhoenix, United States
  • Aim Trials, LLCPlano, United States
  • St. Charles Psychiatric Associates - Midwest Research GroupSaint Charles, United States
  • Clinical Trials of Texas LLCSan Antonio, United States
  • Road Runner Research, LtdSan Antonio, United States
  • SDS Clinical Trials, Inc.Santa Ana, United States
  • CMB Clinical TrialsSantee, United States
  • The Center for Clinical Trials, IncSaraland, United States
  • Sisu BHR, LLCSpringfield, United States
  • University of South Florida, Psychiatry and Behavioral NeurosciencesTampa, United States
  • Family Psychiatry of The WoodlandsThe Woodlands, United States
  • Pacific Clinical Research Management Group LLCUpland, United States
  • Cincy ScienceWest Chester, United States
  • Velocity Clinical Research, Salt Lake CityWest Jordan, United States
  • Neuroscience Research InstituteWest Palm Beach, United States

About the trial

What the trial wants to find out

To evaluate long-term safety exposure

The group in the trial

  • Centanafadine HydrochlorideTreatment being tested

    * 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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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).
Record updated
14 May 2026