Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT04027361
Brief 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.
Study:
NCT04027361
Study Brief:
Protocol Section:
NCT04027361