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

Phase 3

Recruiting

• Conditions: Attention Deficit/Hyperactivity Disorder
• Interventions: Drug: centanafadine capsule; Other: placebo capsule

• Registration Number: NCT05428033
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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 available

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2022-07-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Based High Dose Centanafadine Capsules	centanafadine capsule	Cohort 1, (6 to 12 years of age) Cohort 2, (4 to 5 years of age) High dose - weight-based dosing
Weight Based Low Dose Centanafadine Capsules	centanafadine capsule	Cohort 1, (6 to 12 years of age) Low dose - weight-based dosing
Matching Placebo	placebo capsule	Cohort 1 and Cohort 2 Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6	From baseline to week 6
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

Trial Locations

Locations (1)

For additional information regarding sites, contact 844-687-8522; 🇺🇸 New York, New York, United States