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

Overview

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.

Full Title of Study: “A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Children With Attention-deficit/Hyperactivity Disorder (ADHD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 21, 2023

Interventions

  • Drug: centanafadine capsule
    • capsule
  • Other: placebo capsule
    • capsule

Arms, Groups and Cohorts

  • Experimental: Weight Based High Dose Centanafadine Capsules
    • High dose – weight-based dosing
  • Experimental: Weight Based Low Dose Centanafadine Capsules
    • Low dose – weight-based dosing
  • Placebo Comparator: Matching Placebo
    • Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.

Clinical Trial Outcome Measures

Primary Measures

  • Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6
    • Time Frame: From baseline to week 6

Secondary Measures

  • Clinical Global Impression – Severity – Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6
    • Time Frame: From baseline to week 6
  • Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6
    • Time Frame: From baseline to week 6

Participating in This Clinical Trial

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 or other tic disorder (simple, non-Tourette's tics are allowed), 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. Any lifetime history of suicidal behavior. – 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.

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Otsuka Pharmaceutical Development & Commercialization, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Otsuka Call Center, 844-687-8522, OtsukaRMReconciliation@rmpdc.org

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