Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD.
Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
SUNY Upstate Medical University and Neuroscience Education Institute, Lakewood Ranch, FL, USA.
Meridien Research, Maitland, FL, USA.
Imbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, CT, USA.
Purdue Pharma (Canada), Pickering, Ontario, Canada.
- Published Article
Journal of Attention Disorders
- Publication Date
Apr 01, 2022
To evaluate the efficacy, safety, and duration of action of the once-daily extended-release methylphenidate formulation PRC-063 for the treatment of ADHD in an adult laboratory classroom (ALC). After dose optimization with PRC-063 over 7 weeks, adults with ADHD were randomized to 1 week of double-blind treatment with PRC-063 or placebo that ended with an ALC evaluation. The primary outcome measure was Permanent Product Measure of Performance-Total (PERMP-T) score. Of 288 subjects enrolled, 221 completed the ALC visit. PERMP-T score was significantly higher for PRC-063 versus placebo at every assessment from 1 to 16 hours post-dose at the ALC visit and when averaged over 16 hours post-dose (least-squares mean difference 16.3, 95% confidence interval 7.6-24.9). The most frequent adverse events during dose optimization were headache, decreased appetite, and insomnia. PRC-063 provided rapid and sustained symptom relief in adults with ADHD and was well tolerated. NCT03618030.
Report this publication
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
This record was last updated on 05/07/2022 and may not reflect the most current and accurate biomedical/scientific data available from NLM.
The corresponding record at NLM can be accessed at https://www.ncbi.nlm.nih.gov/pubmed/34189995