Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- ADHD
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 25 years
- Gender
- Both males and females
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 h...
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.
Tracking Information
- NCT #
- NCT04027361
- Collaborators
- Massachusetts General Hospital
- Massachusetts Institute of Technology
- Investigators
- Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
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