A Trial of Centanafadine Long‑term Safety in Children and Adolescents With Attention‑deficit/Hyperactivity Disorder.

Sponsor ID
405-201-00017
Clinicaltrials.gov ID
NCT05279313
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00017
Trial Details
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Age
4 - 18 Years
Therapeutic Area
  • ADHD
    • Sex
    Female & Male
    Trial Dates
    Feb 2022 - Apr 2026
    Healthy Volunteers
    No
    • Rollover subjects from double-blind parent trials inclusion criteria:
    • Subjects who completed the 6-week double-blind treatment period and the 7 (+2) 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.
    • A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline.
    • 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 IMP or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with IMP.
    • 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 3 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.

    Study Summary

    To evaluate long-term safety exposure

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Centanafadine Hydrochloride
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    680
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Rollover subjects from double-blind parent trials inclusion criteria:
    • * Subjects who completed the 6-week double-blind treatment period and the 7 (+2) 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

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Rollover subjects from double-blind parent trials inclusion criteria:
    • Subjects who completed the 6-week double-blind treatment period and the 7 (+2) 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.
    • A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline.
    • 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 IMP or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with IMP.
    • 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 3 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.

    Locations

    Location
    Status
    Location
    Harmonex Neuroscience Research
    Dothan, Alabama, United States, 36303
    Status
    N/A
    Location
    The Center for Clinical Trials, Inc.
    Saraland, Alabama, United States, 36571
    Status
    N/A
    Location
    Southwest Autism Research and Resource Center
    Phoenix, Arizona, United States, 85006
    Status
    N/A
    Location
    Preferred Research Partners, Inc.
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Care Access
    Beverly Hills, California, United States, 90212
    Status
    N/A
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