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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.

Authors
  • Childress, Ann1
  • Cutler, Andrew J2
  • Marraffino, Andrea H3
  • Bhaskar, Sailaja4
  • Donnelly, Graeme5
  • 1 Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
  • 2 SUNY Upstate Medical University and Neuroscience Education Institute, Lakewood Ranch, FL, USA.
  • 3 Meridien Research, Maitland, FL, USA.
  • 4 Imbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, CT, USA.
  • 5 Purdue Pharma (Canada), Pickering, Ontario, Canada. , (Canada)
Type
Published Article
Journal
Journal of Attention Disorders
Publisher
SAGE Publications
Publication Date
Apr 01, 2022
Volume
26
Issue
6
Pages
857–869
Identifiers
DOI: 10.1177/10870547211025610
PMID: 34189995
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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.

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