{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["27(7)"],"submitter":["van Stralen J"],"pubmed_abstract":["<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 ad"],"journal":["Journal of attention disorders"],"pagination":["743-756"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11020119"],"repository":["biostudies-literature"],"pubmed_title":["Real-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."],"pmcid":["PMC11020119"],"pubmed_authors":["Donnelly GAE","Parhar A","Khattak S","Parhar G","Ahmed T","Ratz J","Tourjman V","van Stralen J"],"additional_accession":[]},"is_claimable":false,"name":"Real-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.","description":"<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 ad","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 May","modification":"2025-04-04T12:58:08.735Z","creation":"2025-04-04T12:58:08.735Z"},"accession":"S-EPMC11020119","cross_references":{"pubmed":["37144295"],"doi":["10.1177/10870547231172767"]}}