A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

Study Identifier:
405-201-00021
ClinicalTrials.gov Identifier:
NCT05428033
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Study Details

Medical Condition
  • ADHD
Study Drug
  • Drug: centanafadine capsule
Date
Jul 2022 - Mar 2025
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 4 - 12 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

Protocol 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 screening period, a double-blind treatment period, and follow-up period.

Study Locations

Location
Status
Location
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10012
Status
N/A
© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

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