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

Study Identifier:
405-201-00046
ClinicalTrials.gov Identifier:
NCT04786730
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Study Details

Medical Condition
  • ADHD
Study Drug
  • Drug: Centanafadine
Date
Mar 2021 - Apr 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 4 - 12 Years
Requirements Information
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.

Protocol 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.

Study 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
© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.

July 2025 01US25EUC0279

Requirements information
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.

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