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

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

A Phase 3, Multicenter, Open-label, Long-term Trial Evaluating the Long-term Safety and Tolerability of Once Daily Centanafadine Capsules in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279313
• Other study ID #: 405-201-00017
• Status: Recruiting
• Phase: Phase 3
• Start date: February 24, 2022
• Est. completion date: November 27, 2024

Study information

• Verified date: April 2023
• 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

The primary purpose of this trial is to evaluate the safety and tolerability of centanafadine QD XR in pediatric subjects with ADHD.

Description:

This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17). The study will accept rollover subjects from double-blind parent trials and individuals that did not participate in one of the double-blind parent trials, may enroll as De Novo subjects after meeting all required study entry criteria. All subjects will complete a minimum of 52 weeks and may continue until the last subject enrolled reaches 52 weeks of study treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 27, 2024
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Rollover subjects from double-blind parent trials inclusion criteria:

• Subjects who completed the 6-week double-blind treatment period and the 7- day follow-up in a double-blind parent trial and who, in the opinion of the investigator, could potentially benefit from centanafadine QD XR for ADHD.

De novo subjects inclusion criteria:

• Males and females aged 4 to 17 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 (for children and adolescents aged 4 to 17 years [inclusive]).

• 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.

Rollover subjects from double-blind parent trials exclusion criteria:

• Subjects who, during the double-blind parent trials, experienced, in the opinion of the investigator, poor tolerability to trial medication or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with trial medication.

De novo subjects exclusion criteria:

• A 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, Binge Eating Disorder (adolescents only), Anorexia (adolescents only), Bulimia (adolescents only), 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), MDD with current major depressive episode, or has required treatment within the 6 months prior to screening, or in investigator's opinion, MDD may worsen or could be expected to require treatment during the course of this trial.

• Subjects who are breast-feeding and/or have a positive pregnancy test result prior to receiving 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 weight < 13 kg

• BMI = 40 kg/m2

• Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or are 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 Hydrochloride
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	Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.		Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.