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)
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
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