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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Attention Deficit/Hyperactivity Disorder

Treatments: Other: placebo capsule; Drug: centanafadine capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05428033

405-201-00021

Details and patient eligibility

About

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.

Enrollment: 574 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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574 participants in 3 patient groups, including a placebo group

Weight Based High Dose Centanafadine Capsules

Experimental group

Description:

Cohort 1, (6 to 12 years of age) Cohort 2, (4 to 5 years of age) High dose - weight-based dosing

Treatment:

Drug: centanafadine capsule

Weight Based Low Dose Centanafadine Capsules

Experimental group

Description:

Cohort 1, (6 to 12 years of age) Low dose - weight-based dosing

Treatment:

Drug: centanafadine capsule

Matching Placebo

Placebo Comparator group

Description:

Cohort 1 and Cohort 2 Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.

Treatment:

Other: placebo capsule