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Norepinephrine-Dopamine Reuptake Inhibitor

Centanafadine for Attention-Deficit/Hyperactivity Disorder (ADHD)

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 24 hours
Awards & highlights

Study Summary

This trial is for kids with ADHD who are 4-12 years old.

Eligible Conditions
  • Attention-Deficit/Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Maximal peak plasma concentration (Cmax)

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT04081363
14%
Vessel Puncture Site Bruise
100%
80%
60%
40%
20%
0%
Study treatment Arm
Swallowed Capsules Cohort
Sprinkled Onto Applesauce Cohort

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
246 Previous Clinical Trials
167,119 Total Patients Enrolled

Frequently Asked Questions

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

What is the participant size for this clinical examination?

"Affirmative. Per the records hosted on clinicaltrials.gov, this healthcare study began recruiting patients since March 9th 2021 and is still ongoing as of November 14th 2022. A total of 50 participants are needed to be conscribed from 5 different sites."

Answered by AI

What is the degree of prevalence for this clinical investigation in United States healthcare facilities?

"Currently, the trial is recruiting at 5 distinct medical sites located in Decatur, Las Vegas and San Antonio. Additionally, there are two other facilities available. In order to reduce travel demands, it is best that participants attend a clinic closest to them if they choose to enrol."

Answered by AI

Are there any other studies which have utilized Centanafadine for research purposes?

"Presently, there is only one clinical trial analyzing Centanafadine. This investigation has not yet progressed to the third phase of development. Although it is primarily located at Little Rock, Arkansas, five other medical sites are also conducting trials on this medication."

Answered by AI

Is this experiment novel in comparison to other similar trials?

"Currently, the only active Centanafadine study is established across 5 cities and 1 nation. This pharmaceutical experiment was sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc., commenced in 2021 with 50 participants successfully concluding its first phase of clinical approval. Post-2021, seven additional trials were completed."

Answered by AI

Are there any opportunities for enrolment into this experiment currently?

"This medicinal trial, which was initially posted on March 9th 2021, is still recruiting participants. The listing has been edited up to November 14th 2022 according to clinicaltrials.gov."

Answered by AI

Am I eligible to enroll in this research trial?

"To meet the inclusion criteria for this experiment, applicants must suffer from attention deficit disorder and be between 4 and 12 years of age. The total number of participants required is 50 individuals."

Answered by AI

Does the inclusion criteria for this trial extend to elderly individuals?

"The enrolment process for this trial involves children between the ages of 4 to 12. There are 74 studies available for minors and 31 trials suited to adults over 65 years old."

Answered by AI

Has the U.S. Food and Drug Administration verified Centanafadine as a viable medical treatment?

"As a Phase 1 trial, the available evidence for Centanafadine's safety and efficacy is limited. Thus, our team at Power has ranked its safety as a "1" on a scale from 1 to 3."

Answered by AI

Who else is applying?

What state do they live in?
California
Oregon
Oklahoma
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?
Did not meet criteria
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. For additional information regarding sites, contact 844-687-8522: < 48 hours
~12 spots leftby May 2025