Article ; Online: A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD.
Journal of attention disorders
2024 Volume 28, Issue 6, Page(s) 947–956
Abstract: Objective: To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study.: ... ...
Abstract | Objective: To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study. Method: Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure. Results: Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], Conclusions: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured. |
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MeSH term(s) | Humans ; Young Adult ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Attention Deficit Disorder with Hyperactivity/chemically induced ; Central Nervous System Stimulants/therapeutic use ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Lisdexamfetamine Dimesylate/therapeutic use ; Methylphenidate/therapeutic use ; Treatment Outcome |
Chemical Substances | Central Nervous System Stimulants ; Lisdexamfetamine Dimesylate (SJT761GEGS) ; Methylphenidate (207ZZ9QZ49) |
Language | English |
Publishing date | 2024-02-25 |
Publishing country | United States |
Document type | Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial |
ZDB-ID | 2004350-8 |
ISSN | 1557-1246 ; 1087-0547 |
ISSN (online) | 1557-1246 |
ISSN | 1087-0547 |
DOI | 10.1177/10870547241226634 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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