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

• Status: Not yet recruiting
• Trial end date: 2023-05-21
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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 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.