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

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Children With Attention-deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428033
• Other study ID #: 405-201-00021
• Status: Recruiting
• Phase: Phase 3
• Start date: July 11, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: May 2024
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: Otsuka Call Center
• Phone: 844-687-8522
• Email: OtsukaRMReconciliation[@]rmpdc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 570
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• centanafadine capsule
capsule

Other:
• placebo capsule
capsule

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6		From baseline to week 6
Secondary	Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6		From baseline to week 6