Clinical trial NCT05279313: A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
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 With Attention-deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Centanafadine
ADHD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 680
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this trial is to evaluate the safety and tolerability of centanafadine QD XR in pediatric subjects with ADHD.

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Saraland
country: United States
facility: The Center for Clinical Trials, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Beverly Hills
country: United States
facility: Care Access
state: California
city: Culver City
country: United States
facility: Proscience Research Group
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center, Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials Inc
state: California
city: Santee
country: United States
facility: CMB Clinical Trials
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Norwich
country: United States
facility: Mindscapes Counseling LLC DBA Comprehensive Psychiatric Care, PC
state: Connecticut
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lauderhill
country: United States
facility: West Broward Outpatient Site
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland
state: Florida
city: Miami Lakes
country: United States
facility: RM Medical Research, Inc.
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Trials Solution
state: Florida
city: Miami
country: United States
facility: Care Research Inc
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: ABRI
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Florida International Research Center
state: Florida
city: Miami
country: United States
facility: Anchor Medical Research, LLC
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Apg Research, Llc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Palm Bay
country: United States
facility: Space Coast Neuropsychiatric Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Psychiatry and Behavioral Neurosciences
state: Florida
city: West Palm Beach
country: United States
facility: Neuroscience Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Behavioral Research, LLC
state: Georgia
city: Decatur
country: United States
facility: CenExcel-iResearch, LLC
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research Boise
state: Idaho
city: Chicago
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research Inc
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Bowling Green
country: United States
facility: Qualmedica Research LLC
state: Kentucky
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Springfield
country: United States
facility: Sisu BHR, LLC
state: Massachusetts
city: Bloomfield
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates / Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Vector Clinical Trials
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, INC
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: West Chester
country: United States
facility: Cincy Science
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research, PLLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals LLC
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research Baytown Health LLC
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Javara Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Friendswood
country: United States
facility: Allure Health at Mt. Olympus Medical Research
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical LLC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research Salt Lake City
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Eastside Therapeutic Resource, Inc. dba Core Clinical Research
state: Washington
city: Ottawa
country: Canada
facility: Center for Pediatric Excellence
state: Ontario
city: San Juan
country: Puerto Rico
facility: Barbara Diaz Hernandez MD Research, Inc.
Study officials:
References: