A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Interventions
- Registration Number
- NCT05279313
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 680
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Centanafadine Hydrochloride Centanafadine Hydrochloride * 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
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (84)
CenExcel-iResearch, LLC
🇺🇸Decatur, Georgia, 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
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
InSite Clinical Research, LLC
🇺🇸DeSoto, Texas, United States
Road Runner Research, Ltd.
🇺🇸San Antonio, Texas, United States
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.
🇺🇸Orlando, Florida, United States
West Broward Outpatient Site
🇺🇸Lauderhill, Florida, United States
Accel Research Sites - Maitland
🇺🇸Maitland, Florida, United States
RM Medical Research, Inc.
🇺🇸Miami Lakes, Florida, United States
Florida International Research Center
🇺🇸Miami, Florida, United States
Anchor Medical Research, LLC
🇺🇸Miami, 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
ABRI
🇺🇸Miami, Florida, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Ivetmar Medical Group, LLC
🇺🇸Miami, Florida, United States
Miami Clinical Research
🇺🇸Miami, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Apg Research, Llc
🇺🇸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
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
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
BioBehavioral Research of Austin
🇺🇸Austin, Texas, 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
Inquest Clinical Research Baytown Health LLC
🇺🇸Baytown, Texas, United States
Houston Clinical Trials, LLC
🇺🇸Bellaire, Texas, United States
Javara Inc.
🇺🇸Dallas, Texas, United States
Allure Health at Mt. Olympus Medical Research
🇺🇸Friendswood, Texas, United States
Synergy Groups Medical LLC
🇺🇸Houston, Texas, United States
Velocity Clinical Research Salt Lake City
🇺🇸West Jordan, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Center for Pediatric Excellence
🇨🇦Ottawa, Ontario, Canada
Barbara Diaz Hernandez MD Research, Inc.
🇵🇷San Juan, Puerto Rico
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
AIM Trials, LLC
🇺🇸Plano, Texas, United States
Family Psychiatry of The Woodlands
🇺🇸The Woodlands, Texas, United States
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
🇺🇸Everett, Washington, United States