A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Study Overview
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Brief Summary
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This trial will be conducted to evaluate the efficacy and safety of the Centanafadine extended release (XR) capsules in adolescent subjects (13 - 17 years, inclusive) with ADHD.

Detailed Description
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The trial will consist of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day 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 Adolescents With Attention-deficit/Hyperactivity Disorder

Conditions
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Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: Centanafadine Hydrochloride
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 13 to 17 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. Exclusion Criteria: A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or MDD with current major depressive episode. Subjects who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP. 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. 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: 13 Years
Maximum Age: 17 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: High Dose Centanafadine Hydrochloride<br>328.8 mg total daily dose | Drug: Centanafadine Hydrochloride<br>* Capsule<br>* Other names: Centanafadine QD XR;|
| Experimental: Low Dose Centanafadine Hydrochloride<br>164.4 mg total daily dose | Drug: Centanafadine Hydrochloride<br>* Capsule<br>* Other names: Centanafadine QD XR;|
| Placebo Comparator: Matching Placebo<br> | Other: Placebo<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