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NCT05257265 · ClinicalTrials.gov registry record · Phase 3
A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 459
- Enrollment target
NCT05257265: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT05257265 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 459 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05257265, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 459 participants
- Enrollment target
Study Summary
This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).
Primary Outcome
Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6.
Interventions
- OTHER Placebo
- DRUG Centanafadine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 459 participants |
| Start Date | 2022-02-02 |
| Est. Completion | 2023-10-05 |
| Phase | Phase 3 |
What the finished NCT05257265 record still lists
NCT05257265 is an interventional study that assigns participants to a tested intervention. The registered 459 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05257265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05257265 about?
NCT05257265 is a clinical study titled "A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder". This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).
What is the current status of trial NCT05257265?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 459 participants. The study started on 2022-02-02. Estimated completion is 2023-10-05.
What interventions are being tested in trial NCT05257265?
The interventions under investigation include: Placebo (OTHER), Centanafadine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05257265?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05257265's enrollment target sits among peer trials
459 827th of 2000 higher than 1,174 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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