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Norepinephrine-Dopamine Reuptake Inhibitor
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Phase 1
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- ADHD
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT0408136314%
Vessel Puncture Site Bruise
100%
80%
60%
40%
20%
0%
Study treatment Arm
Swallowed Capsules Cohort
Sprinkled Onto Applesauce Cohort
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-label centanafadineExperimental Treatment1 Intervention
There will be multiple cohorts dosed with open-label centanafadine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine
2019
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
169,048 Total Patients Enrolled