biostudies-literatureUnknown27(7)van Stralen J<h4>Objective</h4>To evaluate the real-world efficacy, safety, and functional outcomes of PRC-063 (multilayer-release methylphenidate) versus lisdexamfetamine (LDX) in ADHD subjects in a phase IV, open-label study.<h4>Method</h4>The primary endpoint was the change in the ADHD-DSM-5 Rating Scale (ADHD-5-RS) total score from baseline to Month 4. Secondary endpoints included a non-inferiority comparison between PRC-063 and LDX and measures of functioning and evening behavior.<h4>Results</h4>One hundred forty-three pediatric and 112 adult subjects were enrolled. Mean ADHD-5-RS scores (standard deviation) were reduced in pediatric (-16.6 [10.4]) and adult (-14.8 [10.6]) subjects treated with PRC-063 (<i>p</i> < .001). PRC-063 was non-inferior to LDX in the pediatric population but not in the adJournal of attention disorders743-756https://www.ebi.ac.uk/biostudies/studies/S-EPMC11020119biostudies-literatureReal-World Efficacy and Safety of Extended-Release Methylphenidate (PRC-063) in the Treatment of ADHD in Pediatric and Adult Subjects: Results of a Phase IV Multicenter Comparison With Lisdexamfetamine Dimesylate.PMC11020119Donnelly GAEParhar AKhattak SParhar GAhmed TRatz JTourjman Vvan Stralen JfalseReal-World Efficacy and Safety of Extended-Release Methylphenidate (PRC-063) in the Treatment of ADHD in Pediatric and Adult Subjects: Results of a Phase IV Multicenter Comparison With Lisdexamfetamine Dimesylate.<h4>Objective</h4>To evaluate the real-world efficacy, safety, and functional outcomes of PRC-063 (multilayer-release methylphenidate) versus lisdexamfetamine (LDX) in ADHD subjects in a phase IV, open-label study.<h4>Method</h4>The primary endpoint was the change in the ADHD-DSM-5 Rating Scale (ADHD-5-RS) total score from baseline to Month 4. Secondary endpoints included a non-inferiority comparison between PRC-063 and LDX and measures of functioning and evening behavior.<h4>Results</h4>One hundred forty-three pediatric and 112 adult subjects were enrolled. Mean ADHD-5-RS scores (standard deviation) were reduced in pediatric (-16.6 [10.4]) and adult (-14.8 [10.6]) subjects treated with PRC-063 (<i>p</i> < .001). PRC-063 was non-inferior to LDX in the pediatric population but not in the ad2023-01-01T00:00:00Z2023 May2025-04-04T12:58:08.735Z2025-04-04T12:58:08.735ZS-EPMC110201193714429510.1177/10870547231172767