Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
NCT04027361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2022-02-18
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.
Conditions
- ADHD
Interventions
- DRUG
-
Amphetamine Extended Release (ER) Tablet 20 mg
A single 20 mg dose of amphetamine ER Tablet, orally administered
Sponsors & Collaborators
-
Massachusetts General Hospital
collaborator OTHER -
Massachusetts Institute of Technology
collaborator OTHER -
Tris Pharma, Inc.
lead INDUSTRY
Principal Investigators
-
Joseph Biederman, MD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-01
- Primary Completion
- 2021-10-15
- Completion
- 2021-10-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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