ERIC Number: EJ1467544
Record Type: Journal
Publication Date: 2022-Dec
Pages: 12
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1087-0547
EISSN: EISSN-1557-1246
Available Date: 0000-00-00
Analysis of Daily Sleep Diary Measures from Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children and Adults with ADHD
Marc Cataldo1; Graeme Donnelly2; Andrew J. Cutler3; Ann Childress4; Jaromir Mikl1; Sailaja Bhaskar5; James Waxmonsky6
Journal of Attention Disorders, v26 n14 p1870-1881 2022
Objective: To compare the effect of a once-daily extended-release methylphenidate formulation (PRC-063) versus placebo on sleep, measured via daily electronic diary in two clinical trials in pediatric (6-12 years) and adult ([greater than or equal to]18 years) patients with attention deficit hyperactivity disorder (ADHD). Method: A diary was completed by adult patients or parents/caregivers of pediatric patients during two randomized, double-blind, placebo-controlled laboratory classroom studies. Following dose optimization of PRC-063, patients were randomized to 1 week of double-blind treatment with PRC-063 or placebo before attending a full-day laboratory classroom session. Results: In the studies, 148 pediatric patients and 239 adult patients were randomized to either PRC-063 or placebo. When compared with the diaries of placebo patients, the sleep diaries in both pediatric and adult patients showed no statistical difference in total sleep time, efficiency, or latency. Conclusion: PRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD.
Descriptors: Sleep, Journal Writing, Measurement Techniques, Children, Adults, Attention Deficit Hyperactivity Disorder
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Publication Type: Journal Articles; Reports - Research
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Grant or Contract Numbers: N/A
Author Affiliations: 1Purdue Pharma L.P., Stamford, CT, USA; 2Purdue Pharma (Canada), Pickering, ON, Canada; 3SUNY Upstate Medical University, Lakewood Ranch, FL, USA; 4Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA; 5Imbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, CT, USA; 6Penn State College of Medicine, Hershey, PA, USA