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NCT04507204 · ClinicalTrials.gov registry record · Phase 4

Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 4 study, sponsored by Purdue Pharma.

Terminated
Registry status
Phase 4
Development phase
267
Enrollment target

NCT04507204: Clinical Trial Phase 4 study, sponsored by Purdue Pharma.

NCT04507204 is a Phase 4 study that was terminated before completion, run by Purdue Pharma. The registered enrollment target is 267 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04507204, a Phase 4 study, was terminated before completion, sponsored by Purdue Pharma.

TERMINATED
Registry status
Phase 4
Development phase
267 participants
Enrollment target

Study Summary

The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (Concerta) over time.

Primary Outcome

The ADHD-RS-5 assesses the frequency and severity of each of the 18 ADHD symptoms among adults based on DSM-5 criteria. Each of the 18 DSM-5 symptoms are rated on a 4 point scale from 0 (never or rarely) to 3 (very often), yielding a total score of 0 to 54. A higher score corresponds to worse ADHD severity.

Interventions

  • DRUG Concerta
  • DRUG Adhansia XR

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2020-07-30
Est. Completion 2022-01-31
Phase Phase 4
Purdue Pharma

54 total trials

Why NCT04507204 stopped before completion

NCT04507204 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower).

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

NCT04507204 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04507204 about?

NCT04507204 is a clinical study titled "Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)". The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with the active comparator group (Concerta) over time.

What is the current status of trial NCT04507204?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 267 participants. The study started on 2020-07-30. Estimated completion is 2022-01-31.

What interventions are being tested in trial NCT04507204?

The interventions under investigation include: Concerta (DRUG), Adhansia XR (DRUG).

Who is sponsoring clinical trial NCT04507204?

This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04507204's enrollment target sits among peer trials

267 320th of 2000 higher than 1,681 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT04507204, the US trial registry maintained by the National Library of Medicine. NCT04507204 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.