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

ADHD Clinical Trial

Official title:
Driving Performance in Patients Aged 18 to 25 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) After a Single-Dose of Amphetamine Extended-Release Tablets: A Pilot, Double-Blind, Placebo-Controlled Study

Clinical Trial 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.

Clinical Trial Description

At a single US-based study site, a driving simulation will be used to assess the effect on driving performance for the co-primary endpoints, study subjects' driving performance at 45 minutes and 10 hours post-dose, compared with placebo. Eligible subjects will be prescreened for ADHD but otherwise healthy, aged 18-25 years. Driving simulations that simulate common driving events to which the study subject must react. The reactions to each event will be assessed. Using a parallel-group design, subjects will be assessed while on study drug, and while on placebo. Safety assessments will include spontaneously reported treatment-emergent adverse events and vital signs at 4 hours post-dose. ;

Study Design

Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity
Clinical Trial Details
NCT number NCT04027361
Study type Interventional
Source Tris Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date October 1, 2019
Completion date October 15, 2021
View Details
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