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NCT03605836 · ClinicalTrials.gov registry record · Phase 3

A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

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

Completed
Registry status
Phase 3
Development phase
590
Enrollment target

NCT03605836: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT03605836 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 590 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03605836, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
590 participants
Enrollment target

Study Summary

This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.

Primary Outcome

The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Mixed-effect model repeated measure (MMRM) was used for the analysis.

Interventions

  • OTHER Placebo
  • DRUG Centanafadine SR

Trial Details

FieldValue
Enrollment Target 590 participants
Start Date 2019-01-16
Est. Completion 2020-05-14
Phase Phase 3

What the finished NCT03605836 record still lists

NCT03605836 is an interventional study that assigns participants to a tested intervention. The registered 590 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 (24% lower).

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

NCT03605836 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03605836 about?

NCT03605836 is a clinical study titled "A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder". This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.

What is the current status of trial NCT03605836?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 590 participants. The study started on 2019-01-16. Estimated completion is 2020-05-14.

What interventions are being tested in trial NCT03605836?

The interventions under investigation include: Placebo (OTHER), Centanafadine SR (DRUG).

Who is sponsoring clinical trial NCT03605836?

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 NCT03605836's enrollment target sits among peer trials

590 643rd of 2000 higher than 1,356 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 NCT03605836, the US trial registry maintained by the National Library of Medicine. NCT03605836 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.