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NCT04027361 · ClinicalTrials.gov registry record · Phase 2

Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)

A Phase 2 study, sponsored by Tris Pharma.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT04027361: Completed Phase 2 study, sponsored by Tris Pharma.

NCT04027361 is a Phase 2 study that has completed, run by Tris Pharma. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04027361, a Phase 2 study, has completed, sponsored by Tris Pharma.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effect on driving performance of a single dose of amphetamine extended-release tablets (20 mg/tablet) compared with placebo at 45 minutes and 10 hours post-dose in young adults with ADHD.

Primary Outcome

Measurement of reaction time across a series of driving simulations

Interventions

  • DRUG Amphetamine Extended Release (ER) Tablet 20 mg

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2019-10-01
Est. Completion 2021-10-15
Phase Phase 2
Tris Pharma

14 total trials

What the finished NCT04027361 record still lists

NCT04027361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 1 intervention - of which Amphetamine Extended Release (ER) Tablet 20 mg is the first listed.

NCT04027361 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04027361 about?

NCT04027361 is a clinical study titled "Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)". The purpose of this study is to assess the effect on driving performance of a single dose of amphetamine extended-release tablets (20 mg/tablet) compared with placebo at 45 minutes and 10 hours post-dose in young adults with ADHD.

What is the current status of trial NCT04027361?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2019-10-01. Estimated completion is 2021-10-15.

What interventions are being tested in trial NCT04027361?

The interventions under investigation include: Amphetamine Extended Release (ER) Tablet 20 mg (DRUG).

Who is sponsoring clinical trial NCT04027361?

This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04027361's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT04027361, the US trial registry maintained by the National Library of Medicine. NCT04027361 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.