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NCT05428033 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
574
Enrollment target

NCT05428033: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT05428033 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 574 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05428033, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
574 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG centanafadine capsule
  • OTHER placebo capsule

Trial Details

FieldValue
Enrollment Target 574 participants
Start Date 2022-07-11
Est. Completion 2025-03-17
Phase Phase 3

What the finished NCT05428033 record still lists

NCT05428033 is an interventional study that assigns participants to a tested intervention. The registered 574 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).

The record links to 0 conditions, and to 2 interventions - of which centanafadine capsule is the first listed.

NCT05428033 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05428033 about?

NCT05428033 is a clinical study titled "A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)". 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.

What is the current status of trial NCT05428033?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 574 participants. The study started on 2022-07-11. Estimated completion is 2025-03-17.

What interventions are being tested in trial NCT05428033?

The interventions under investigation include: centanafadine capsule (DRUG), placebo capsule (OTHER).

Who is sponsoring clinical trial NCT05428033?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05428033's enrollment target sits among peer trials

574 663rd of 2000 higher than 1,338 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05428033, the US trial registry maintained by the National Library of Medicine. NCT05428033 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.