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Norepinephrine-Dopamine Reuptake Inhibitor

Centanafadine Hydrochloride 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 study how well Centanafadine XR capsules work in treating adolescents with ADHD, as well as how safe the medication is.

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)
Secondary outcome measures
Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)
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: Low Dose Centanafadine HydrochlorideExperimental Treatment1 Intervention
164.4 mg total daily dose
Group II: High Dose Centanafadine HydrochlorideExperimental Treatment1 Intervention
328.8 mg total daily dose
Group III: Matching PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,590 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,898 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Centanafadine Hydrochloride (Norepinephrine-Dopamine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05257265 — Phase 3
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: High Dose Centanafadine Hydrochloride, Low Dose Centanafadine Hydrochloride, Matching Placebo
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Centanafadine Hydrochloride Highlights & Side Effects. Trial Name: NCT05257265 — Phase 3
Centanafadine Hydrochloride (Norepinephrine-Dopamine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05257265 — Phase 3

Frequently Asked Questions

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

Has Centanafadine Hydrochloride received FDA approval?

"Centanafadine Hydrochloride has undergone multiple rounds of testing with positive results, so it received a score of 3 for safety."

Answered by AI

Does this research include elderly individuals as participants?

"As this clinical trial's inclusion criteria permit, the minimum age for enrollment is 13 years old and the maximum age is 17 years old."

Answered by AI

Who can sign up to participate in this research?

"This study is looking for 450 adolescents, aged 13 to 17, who have been diagnosed with attention deficit hyperactivity disorder (ADHD). Eligible patients must meet the following criteria: Males and females aged 13 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., A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline for all subjects., A score of 4 or higher on the CGI-S-ADHD at baseline."

Answered by AI

Are people still able to sign up for this experiment?

"That is correct. The online clinicaltrials.gov registry shows that this research is actively looking for new participants. The listing was first created on February 2nd, 2022 and most recently updated on August 31st, 2022. They are hoping to enroll 450 individuals at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
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 Adolescents With Attention- Deficit/Hyperactivity Disorder
2022. "A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05257265.
~141 spots leftby May 2025
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