Status:
COMPLETED
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Attention-deficit Hyperactivity Disorder
Eligibility:
All Genders
4-12 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Key
- 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).
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04786730
Start Date
March 9 2021
End Date
April 26 2023
Last Update
July 13 2023
Active Locations (5)
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1
For additional information regarding sites, contact 844-687-8522
Little Rock, Arkansas, United States, 72211
2
For additional information regarding sites, contact 844-687-8522
Decatur, Georgia, United States, 30030
3
For additional information regarding sites, contact 844-687-8522
Las Vegas, Nevada, United States, 89128
4
For additional information regarding sites, contact 844-687-8522
Oklahoma City, Oklahoma, United States, 73106