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

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ClinicalTrials.gov Identifier: NCT05428033

Recruitment Status : Recruiting

First Posted : June 22, 2022

Last Update Posted : May 6, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information

First Submitted Date ^ICMJE

June 16, 2022

First Posted Date ^ICMJE

June 22, 2022

Last Update Posted Date

May 6, 2024

Actual Study Start Date ^ICMJE

July 11, 2022

Estimated Primary Completion Date

October 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: From baseline to week 6 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6 [ Time Frame: From baseline to week 6 ]
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6 [ Time Frame: From baseline to week 6 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Attention Deficit/Hyperactivity Disorder

Intervention ^ICMJE

Drug: centanafadine capsule
capsule
Other Names:
- centanafadine
- centanafadine XR
- EB-1020
Other: placebo capsule
capsule
Other Names:
- placebo comparator
- matching placebo

Study Arms ^ICMJE

Experimental: 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

Intervention: Drug: centanafadine capsule
Experimental: Weight Based Low Dose Centanafadine Capsules
Cohort 1, (6 to 12 years of age)

Low dose - weight-based dosing

Intervention: Drug: centanafadine capsule
Placebo Comparator: 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.

Intervention: Other: placebo capsule

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

570

Original Estimated Enrollment ^ICMJE

450

Estimated Study Completion Date ^ICMJE

October 30, 2025

Estimated Primary Completion Date

October 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

4 Years to 12 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Otsuka Call Center

844-687-8522

OtsukaRMReconciliation@rmpdc.org

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05428033

Other Study ID Numbers ^ICMJE

405-201-00021

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Clinical Study Report (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/
URL:	https://clinical-trials.otsuka.com