NCT04027361

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Amphetamine Extended Release (ER) Tablet 20 mg	A single 20 mg dose of amphetamine ER Tablet, orally administered

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2019-07-22
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study