A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Recruiting at 4 trial locations
OC
Overseen ByOtsuka Call Center
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment for children aged 4 to 12 years who have ADHD. The goal is to see how effective and safe the treatment is over time.
Eligibility Criteria
Inclusion Criteria
Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
You have been diagnosed with ADHD by a doctor using specific criteria from the DSM-5 and confirmed by a special interview for children and teenagers.
Exclusion Criteria
You have a history of serious medical conditions affecting your brain, skin, liver, kidneys, blood, immune system, heart, lungs, or digestive system.
You have a history of memory or thinking problems, psychiatric symptoms that are caused by another health condition or substance use, or a history of psychotic symptoms.
You have conditions that affect your development, such as autism spectrum disorder.
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Treatment Details
Interventions
- Centanafadine (Norepinephrine-Dopamine Reuptake Inhibitor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-label centanafadineExperimental Treatment1 Intervention
There will be multiple cohorts dosed with open-label centanafadine.
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Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
Trials
271
Recruited
170,000+
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University