Norepinephrine-Dopamine Reuptake Inhibitor
Centanafadine Hydrochloride for Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
Recruiting
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
A score of 4 or higher on the CGI-S-ADHD at baseline.
Be younger than 18 years old
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upminimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Study Summary
This trial is to see if a new medicine for ADHD is safe and tolerated by kids.
Eligible Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a score of 4 or higher on a test that measures symptoms of attention deficit hyperactivity disorder (ADHD).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Centanafadine HydrochlorideExperimental Treatment1 Intervention
Adolescents (13 to 17 years of age, inclusive) to receive 328.8 mg daily.
Children (4 to 12 years of age, inclusive) will receive weight-based doses of centanafadine ranging from 82.2 mg to 328.8 mg daily
Find a site
Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
244 Previous Clinical Trials
163,672 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,657 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please inform me of the risks associated with taking Centanafadine Hydrochloride?
"Centanafadine Hydrochloride, which is currently in Phase 3 clinical trials, was given a safety rating of 3. This reflects the presence of some efficacy data as well as multiple rounds of supportive safety data."
Answered by AI
Are geriatric patients accepted into this program?
"According to the information provided, patients that meet the age criteria of 4-17 years old are eligible for this trial. There are a total of 112 studies targeting people under 18 and 40 for those over 65."
Answered by AI
To whom is this study available?
"Patients that have been diagnosed with attention deficit hyperactivity disorder and are between the ages of 4-17 may be accepted into this clinical trial. Currently, the study is looking to enroll around 700 patients."
Answered by AI
Are people with the target condition eligible to participate in this research right now?
"Yes, this is an ongoing trial that was posted on February 24th, 2022 and last updated August 31st, 2022. The study will take place at a single site but 700 patients are needed for the clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
New York
Other
Pennsylvania
How old are they?
< 18
18 - 65
What site did they apply to?
For additional information regarding sites, contact 844-687-8522
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria