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

NCT ID: NCT05428033

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2025-03-17

Brief 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.

Conditions

Attention Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Weight Based High Dose Centanafadine Capsules

Cohort 1, (6 to 12 years of age)

Cohort 2, (4 to 5 years of age)

High dose - weight-based dosing

Group Type: EXPERIMENTAL

centanafadine capsule

Intervention Type: DRUG

capsule

Weight Based Low Dose Centanafadine Capsules

Cohort 1, (6 to 12 years of age)

Low dose - weight-based dosing

Group Type: EXPERIMENTAL

centanafadine capsule

Intervention Type: DRUG

capsule

Matching Placebo

Cohort 1 and Cohort 2

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

Group Type: PLACEBO_COMPARATOR

placebo capsule

Intervention Type: OTHER

capsule

Interventions

centanafadine capsule

capsule

Intervention Type: DRUG

placebo capsule

capsule

Intervention Type: OTHER

Other Intervention Names

centanafadine; centanafadine XR; EB-1020; placebo comparator; matching placebo

Eligibility 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, 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

For additional information regarding sites, contact 844-687-8522

New York, New York, United States

Countries

United States

Other Identifiers

405-201-00021

Identifier Type: -

Identifier Source: org_study_id