Centanafadine for Attention-Deficit/Hyperactivity Disorder (ADHD)

For additional information regarding sites, contact 844-687-8522, San Antonio, TX
Attention-Deficit/Hyperactivity Disorder (ADHD)Centanafadine - Drug
Eligibility
4 - 12
All Sexes
What conditions do you have?
Select

Study Summary

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

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 24 hours

24 hours
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)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Open-label centanafadine
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Centanafadine · No Placebo Group · Phase 1

Open-label centanafadine
Drug
Experimental Group · 1 Intervention: Centanafadine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
244 Previous Clinical Trials
164,645 Total Patients Enrolled

Eligibility Criteria

Age 4 - 12 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with ADHD by a doctor using specific criteria from the DSM-5 and confirmed by a special interview for children and teenagers.

Who else is applying?

What state do they live in?
Oklahoma50.0%
California25.0%
Oregon25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
For additional information regarding sites, contact 844-687-8522100.0%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%

How responsive is this trial?

Most responsive sites:
  1. For additional information regarding sites, contact 844-687-8522: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.