Status:
COMPLETED
A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Attention Deficit/Hyperactivity Disorder
Eligibility:
All Genders
4-12 years
Phase:
PHASE3
Brief Summary
This trial will be conducted to evaluate the efficacy of centanafadine QD XR versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screeni...
Eligibility Criteria
Inclusion
- Males and females aged 4 to 12 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 for all subjects.
- 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.
Exclusion
- 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, 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), or MDD with current major depressive episode.
- 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. A history of suicidal behavior (over the last 6 months).
- BMI ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on US CDC criteria.
- Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2025
Estimated Enrollment :
574 Patients enrolled
Trial Details
Trial ID
NCT05428033
Start Date
July 11 2022
End Date
March 17 2025
Last Update
July 22 2025
Active Locations (1)
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1
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10012