Abstract
BackgroundDuration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using the simulated adult workplace environment.MethodsAfter open-label dose optimization (4-week) with LDX, 30-70 mg/d, subjects entered a 2-week randomized, double-blind, placebo-controlled crossover phase. Efficacy assessments included the Permanent Product Measure of Performance (PERMP) total score (attempted+correct) measured predose and from 2 to 14 hours postdose, averaged across postdose sessions (primary) and at each time point vs placebo (secondary), and ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts at baseline and crossover visits. Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms.ResultsOf 127 randomized subjects, 105 were in the intention-to-treat population and 103 completed the study. While receiving LDX vs placebo, adults had greater improvement (P < .0001) in average PERMP total scores as measured by difference in least squares (LS) mean (95% CI): 23.4 (15.6, 31.2). Absolute (P ≤ .0017 for each time point) and change from predose (P < .001 for each time point) PERMP total scores were greater at all postdose time points from 2 to 14 h for adults while receiving LDX vs placebo. LDX demonstrated efficacy vs placebo (P < .0001) by the difference in LS mean (95% CI) for ADHD-RS-IV total scores: -11.5 (-14.2, -8.9). TEAEs (≥ 10%) during dose optimization were decreased appetite, dry mouth, headache, and insomnia; no TEAEs ≥ 5% were reported during crossover phase for adults receiving LDX.ConclusionsLDX significantly improved PERMP scores vs placebo and maintained improvement throughout the day from the first (2 hours) to last (14 hours) postdose time point vs placebo in adults with ADHD.Trial RegistrationClinicalTrials.gov Identifier: NCT00697515Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) http://www.clinicaltrials.gov/ct2/show/NCT00697515?term=NCT00697515&rank=1
Highlights
Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using the simulated adult workplace environment
LDX demonstrated efficacy compared with placebo by the Permanent Product Measure of Performance (PERMP) and other assessments in the laboratory school setting at 12 and 13 hours postdose in children with ADHD [15,16]
PERMP [21], a skill-matched test consisting of simple math problems to be attempted and completed at multiple time points throughout the simulated adult workplace environment (AWE) session, is used to measure the ability to stay on task and attend to work
Summary
Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using the simulated adult workplace environment. Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant indicated for the treatment of ADHD in children 6 to 12 years of age and in adults in the United States. LDX demonstrated efficacy compared with placebo by the Permanent Product Measure of Performance (PERMP) and other assessments in the laboratory school setting at 12 and 13 hours postdose in children with ADHD [15,16]. In another pediatric study, LDX was effective throughout the day, as measured by parent ratings [17]. LDX demonstrated a safety profile consistent with long-acting stimulant use [15,16,17]
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