European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder

David Coghill (Lead / Corresponding author), Tobias Banaschewski, Michel Lecendreux, Cesar Soutullo, Mats Johnson, Alessandro Zuddas, Colleen Anderson, Richard Civil, Nicholas Higgins, Andrew Lyne, Liza Squires

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    81 Citations (Scopus)

    Abstract

    This study evaluated the efficacy and safety of lisdexamfetamine dimesylate (LDX) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in Europe. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm. Patients (6-17 years old) with a baseline ADHD Rating Scale version IV (ADHD-RS-IV) total score =28 were randomized (1:1:1) to dose-optimized LDX (30, 50, or 70mg/day), OROS-MPH (18, 36, or 54mg/day) or placebo for 7 weeks. Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement (CGI-I) rating, respectively. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs. Of 336 patients randomized, 196 completed the study. The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -18.6 (95% confidence interval [CI]: -21.5 to -15.7) (p<0.001; effect size, 1.80). The difference between OROS-MPH and placebo
    in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was13.0(95% CI: 5.9 to 10.2) (p<0.001; effect size, 1.26). The proportions (95% CI) of patients showing improvement (CGI-I of 1 or 2) at endpoint were 78% (70–86), 14% (8–21), and 61% (51–70) for LDX, placebo, and OROS-MPH. The most common TEAEs for LDX were decreased
    appetite, headache, and insomnia. Mean changes in vital signs were modest and consistent with the known profile of LDX. LDX was effective and generally well tolerated in children and adolescents with ADHD.

    Original languageEnglish
    Pages (from-to)1208-1218
    Number of pages11
    JournalEuropean Neuropsychopharmacology
    Volume23
    Issue number10
    DOIs
    Publication statusPublished - Oct 2013

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