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

• Status: Recruiting
• Trial end date: 2023-05-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

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 or other tic disorder (simple, non-Tourette's tics are allowed), Generalized Anxiety Disorder severe enough to interfere with study 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 study conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with study 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. 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.

• A history of dermatologic adverse reactions secondary to any drug exposure.