A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention‑deficit Hyperactivity Disorder

Sponsor ID
405-201-00046
Clinicaltrials.gov ID
NCT04786730
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00046
Trial Details
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Age
4 - 12 Years
Therapeutic Area
  • ADHD
    • Sex
    Female & Male
    Trial Dates
    Mar 2021 - Apr 2023
    Healthy Volunteers
    No
    • Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
    • A diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
    • Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms.
    • Subjects with developmental disorders, such as autism spectrum disorder.
    • Subjects with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient \< 70, or clinical evidence, or a social or school history that is suggestive of intellectual disability.
    • Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/ AIDS, or chronic hepatitis B or C.
    • Subjects who have history of clinically significant tachycardia or hypertension.

    Study Summary

    This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Centanafadine
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    50
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
    • * A diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

    Exclusion Criteria

    • * Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms.
    • * Subjects with developmental disorders, such as autism spectrum disorder.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
    • A diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
    Exclusion Criteria:
    • Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms.
    • Subjects with developmental disorders, such as autism spectrum disorder.
    • Subjects with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient \< 70, or clinical evidence, or a social or school history that is suggestive of intellectual disability.
    • Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/ AIDS, or chronic hepatitis B or C.
    • Subjects who have history of clinically significant tachycardia or hypertension.

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    For additional information regarding sites, contact 844-687-8522
    Decatur, Georgia, United States, 30030
    Status
    N/A
    Location
    For additional information regarding sites, contact 844-687-8522
    Las Vegas, Nevada, United States, 89128
    Status
    N/A
    Location
    For additional information regarding sites, contact 844-687-8522
    Oklahoma City, Oklahoma, United States, 73106
    Status
    N/A
    Location
    For additional information regarding sites, contact 844-687-8522
    San Antonio, Texas, United States, 78229
    Status
    N/A

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