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Norepinephrine-Dopamine Reuptake Inhibitor
Centanafadine for 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
Males and females aged 4 to 17 years (inclusive) at the time of informed consent/assent.
A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI-KID (for children and adolescents aged 4 to 17 years [inclusive]).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
Awards & highlights
Study Summary
This trial is to see if a new medicine for ADHD is safe and tolerated by kids.
Who is the study for?
This trial is for children and adolescents aged 4 to 17 with ADHD who completed a previous double-blind study. They must have an ADHD diagnosis, significant symptoms, and in some cases, inadequate response to psychotherapy. Excluded are those with certain severe psychiatric conditions or history of drug-related skin reactions.Check my eligibility
What is being tested?
The trial tests the long-term safety of Centanafadine Hydrochloride, taken once daily as an extended-release (XR) medication for treating ADHD in pediatric patients. It follows up on participants from a prior study to assess tolerability over a longer period.See study design
What are the potential side effects?
While specific side effects aren't listed here, the focus is on evaluating any adverse reactions related to skin health due to past drug exposure and overall tolerability issues that may arise during prolonged use of Centanafadine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 17 years old.
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I have been diagnosed with ADHD according to DSM-5 criteria.
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My ADHD symptoms score is 28 or higher.
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I am between 4 and 17 years old.
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I have been diagnosed with ADHD according to DSM-5 criteria.
Select...
My ADHD symptoms score is 28 or higher.
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.
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine Hydrochloride
2022
Completed Phase 3
~460
Find a Location
Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,349 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,657 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ADHD symptoms score is 28 or higher.You have a score of 4 or higher on a test that measures symptoms of attention deficit hyperactivity disorder (ADHD).You have certain mental health conditions like Tourette's Disorder, severe anxiety, panic disorder, conduct disorder, psychosis, post-traumatic stress disorder, bipolar disorder, autism spectrum disorder, binge eating disorder, anorexia, bulimia, oppositional defiant disorder, or severe obsessive-compulsive disorder. If you have major depressive disorder, you either had treatment within the last 6 months or may require treatment during the trial.I am between 4 and 17 years old.I am 4 or 5 years old and need medication for my severe condition, despite not trying psychotherapy.I finished a 6-week ADHD treatment trial and my doctor thinks I could benefit from more.I am between 4 and 17 years old.I am 4 or 5 years old and need medication for my condition, despite psychotherapy.You have a history of suicide attempts or current thoughts of harming yourself.I have been diagnosed with ADHD according to DSM-5 criteria.I have been diagnosed with ADHD according to DSM-5 criteria.I am not pregnant or breastfeeding.You have a score of 4 or higher on the CGI-S-ADHD at baseline.I finished a 6-week ADHD treatment trial and my doctor thinks I could benefit from more.My body weight is less than 13 kg.My ADHD symptoms score is 28 or higher.I have recently started, stopped, or changed ADHD therapy.You have experienced skin reactions from taking medication before.
Research Study Groups:
This trial has the following groups:- Group 1: Centanafadine Hydrochloride
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Met criteria
Did not meet criteria
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