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)

  • STATUS
    Recruiting
  • End date
    May 21, 2024
  • participants needed
    700
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 16 September 2022
psychotherapy
hyperactivity

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.

Details
Condition Attention Deficit/Hyperactivity Disorder
Treatment Centanafadine Hydrochloride
Clinical Study IdentifierNCT05279313
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

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

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 or other tic disorder (simple, non-Tourette's tics are allowed), 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 study 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, any lifetime history of suicidal behavior
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
A history of dermatologic adverse reactions secondary to any drug exposure
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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