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.

Abstract

OBJECTIVE\nTo 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).\n\n\nMETHOD\nAfter dose optimization with PRC-063 over 7\u2009weeks, adults with ADHD were randomized to 1\u2009week 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.\n\n\nRESULTS\nOf 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\u2009hours post-dose at the ALC visit and when averaged over 16\u2009hours 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.\n\n\nCONCLUSION\nPRC-063 provided rapid and sustained symptom relief in adults with ADHD and was well tolerated. NCT03618030.