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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Attention Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: centanafadine capsule
* Other: placebo capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Based High Dose Centanafadine Capsules<br>High dose - weight-based dosing | Drug: centanafadine capsule<br>* capsule<br>* Other names: EB-1020;|
| Experimental: Weight Based Low Dose Centanafadine Capsules<br>Low dose - weight-based dosing | Drug: centanafadine capsule<br>* capsule<br>* Other names: EB-1020;|
| Placebo Comparator: Matching Placebo<br>Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color. | Other: placebo capsule<br>* capsule<br>* Other names: matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | From baseline to week 6 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Centanafadine, ADHD