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

NCT05257265 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 405-201-00016
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

Centanafadine; ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)

  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

Study Arms (3)

Centanafadine 164.4 mg

EXPERIMENTAL

Participants received centanafadine hydrochloride 164.4 milligrams (mg) XR capsules, orally, QD up to 6 weeks.

Drug: Centanafadine Hydrochloride

Centanafadine 328.8 mg

EXPERIMENTAL

Participants received centanafadine hydrochloride 328.8 mg XR capsules, orally, QD up to 6 weeks.

Drug: Centanafadine Hydrochloride

Placebo

PLACEBO COMPARATOR

Participants received centanafadine matching placebo capsules, orally, QD up to 6 weeks.

Other: Placebo

Interventions

Centanafadine Hydrochloride DRUG

Capsule

Also known as: Centanafadine QD XR

Centanafadine 164.4 mg; Centanafadine 328.8 mg

Placebo OTHER

Capsule

Also known as: Matching Placebo

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent.
• A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
• A minimum symptoms total raw score of ≥ 28 on the Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) at baseline for all participants.
• A score of 4 or higher on the Clinical Global Impression - Severity - Attention Deficit/Hyperactivity Disorder (CGI-S-ADHD) at baseline.

You may not qualify if:

• 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 major depressive disorder (MDD) with current major depressive episode.
• Participants who are breast-feeding and/or have a positive pregnancy test result prior to receiving investigational medicinal product (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).
• Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on United States (US) Centers for Disease Control and Prevention (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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

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

New York, New York, 10012, United States

Location

Related Publications (1)

• Ward CL, Childress AC, Jin N, Turkoglu O, Skubiak T, Wilens TE. Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jul 4:S0890-8567(25)00327-2. doi: 10.1016/j.jaac.2025.06.023. Online ahead of print.

  PMID: 40619095 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: February 2, 2022
• Primary Completion: September 29, 2023
• Study Completion: October 5, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (1)