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Norepinephrine-Dopamine Reuptake Inhibitor

centanafadine capsule for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3
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 from baseline to week 6
Awards & highlights

Study Summary

This trial will test how well centanafadine QD XR (a medication) works compared to placebo in treating children 4-12 years old with ADHD.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6
Secondary outcome measures
Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Weight Based Low Dose Centanafadine CapsulesExperimental Treatment1 Intervention
Low dose - weight-based dosing
Group II: Weight Based High Dose Centanafadine CapsulesExperimental Treatment1 Intervention
High dose - weight-based dosing
Group III: Matching PlaceboPlacebo Group1 Intervention
Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,545 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,907 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Centanafadine (Norepinephrine-Dopamine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05428033 — Phase 3
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Matching Placebo, Weight Based High Dose Centanafadine Capsules, Weight Based Low Dose Centanafadine Capsules
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Centanafadine Highlights & Side Effects. Trial Name: NCT05428033 — Phase 3
Centanafadine (Norepinephrine-Dopamine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05428033 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project have an age limit?

"The age range that is eligible for this clinical trial according to the current criteria is 4 to 12 years old."

Answered by AI

Are people with the qualifying condition able to enroll in this research project at this time?

"That is correct. The website provides updated information that recruitment is ongoing for the 450 patients at a single site."

Answered by AI

How many people are being included in this clinical trial?

"That is correct, the clinical trial mentioned is currently looking for patients. As seen on clinicaltrials.gov, the posting went up on 7/11/2022 and was updated as recently as 8/31/2022. They are aiming to have 450 people sign up in total from 1 location."

Answered by AI

Who meets the inclusion criteria for this particular experiment?

"This study is looking for 450 young patients that have hyperkinesis. In order to be eligible, potential participants must meet the following requirements: They must be between 4 and 12 years old (inclusive), have a primary diagnosis of ADHD based on DSM-5 criteria as confirmed with the MINI-KID, have a minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline, score 4 or higher on the CGI-S-ADHD at baseline, and if they are aged 4 or 5 years only: has failed adequate psychotherapy or in the investigator's opinion, is severe enough to"

Answered by AI

Are there any harmful side effects associated with taking centanafadine capsules?

"Centanafadine capsule safety is rated a 3 because it has undergone Phase 3 clinical trials. This indicates that, while more research needs to be done, the drug's efficacy has been supported and multiple rounds of data support its safety."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
New York
How old are they?
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
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)
2022. "A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05428033.
All > Adhd
~164 spots leftby Apr 2025
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