NCT05428033 is a Phase 3 clinical trial of centanafadine capsule in Attention Deficit/Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT05428033?

NCT05428033 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT05428033?

Interventions in NCT05428033: centanafadine capsule, placebo capsule.

What condition does NCT05428033 study?

NCT05428033 studies Attention Deficit/Hyperactivity Disorder.

Is NCT05428033 still recruiting?

NCT05428033 is currently completed. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05428033

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

Completed Phase 3 Last updated 13 April 2026

What this trial tests

Phase 3 trial testing centanafadine capsule in Attention Deficit/Hyperactivity Disorder in 574 participants. Completed in 17 March 2025.

Timeline

11 July 2022

Primary endpoint
17 March 2025

17 March 2025

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	574
Start date	11 July 2022
Primary completion	17 March 2025
Estimated completion	17 March 2025
Sites	1 location across United States

Drugs / interventions tested

centanafadine capsule
placebo capsule

Conditions studied

Attention Deficit/Hyperactivity Disorder — all drugs for Attention Deficit/Hyperactivity Disorder →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 4 to 12, any sex, with Attention Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial will be conducted to evaluate the efficacy of centanafadine once daily (QD) extended release (XR) versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screening period, a double-blind treatment period, and follow-up period.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
Treatment of ADHD: Drugs, psychological therapies, devices, complementary and alternative methods as well as the trends in clinical trials.
Nazarova VA, Sokolov AV, Chubarev VN, Tarasov VV, et al · · 2022 · cited 44× · PMID 36467081 · DOI 10.3389/fphar.2022.1066988
Serotonergic Drugs for the Treatment of Attention-Deficit/Hyperactivity Disorder: A Review of Past Development, Pitfalls and Failures, and a Look to the Future.
Chepke C, Brunner E, Cutler AJ. · · 2024 · cited 3× · PMID 39263202 · DOI 10.64719/pb.4503
Efficacy of Centanafadine for Executive Functioning and Learning Problems in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.
Wilens TE, Oberdhan D, Jin N, Skubiak T, et al · · 2026 · PMID 41958186 · DOI 10.1177/10445463261441745
Poster Abstracts - Academy of Managed Care Pharmacy 2024
· 2024

Verify or expand the search:

Other recruiting trials for Attention Deficit/Hyperactivity Disorder

Currently open trials in the same condition.

NCT05930886 — Focus Groups in Ethnically and Racially Diverse Families · recruiting
NCT05279313 — A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder. · Phase 3 · active not recruiting

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Trials by the same sponsor.

NCT07525960 — A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for · Phase 1 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults · Phase 1 · not yet recruiting
NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05428033 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05428033.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing