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European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder.
Eur Neuropsychopharmacol 2013; 23(10):1208-18EN

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 70 mg/day), OROS-MPH (18, 36, or 54 mg/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 was -13.0 (95% CI: -15.9 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.

Authors+Show Affiliations

Division of Neuroscience, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK. Electronic address: d.r.coghill@dundee.ac.uk.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23332456

Citation

Coghill, David, et al. "European, Randomized, Phase 3 Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-deficit/hyperactivity Disorder." European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, vol. 23, no. 10, 2013, pp. 1208-18.
Coghill D, Banaschewski T, Lecendreux M, et al. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013;23(10):1208-18.
Coghill, D., Banaschewski, T., Lecendreux, M., Soutullo, C., Johnson, M., Zuddas, A., ... Squires, L. (2013). European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, 23(10), pp. 1208-18. doi:10.1016/j.euroneuro.2012.11.012.
Coghill D, et al. European, Randomized, Phase 3 Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-deficit/hyperactivity Disorder. Eur Neuropsychopharmacol. 2013;23(10):1208-18. PubMed PMID: 23332456.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. AU - Coghill,David, AU - Banaschewski,Tobias, AU - Lecendreux,Michel, AU - Soutullo,Cesar, AU - Johnson,Mats, AU - Zuddas,Alessandro, AU - Anderson,Colleen, AU - Civil,Richard, AU - Higgins,Nicholas, AU - Lyne,Andrew, AU - Squires,Liza, Y1 - 2013/01/15/ PY - 2012/06/27/received PY - 2012/11/27/accepted PY - 2013/1/22/entrez PY - 2013/1/22/pubmed PY - 2014/4/25/medline KW - Adolescent KW - Attention deficit disorder with hyperactivity KW - Central nervous system stimulants KW - Child KW - Lisdexamfetamine dimesylate KW - Prodrugs SP - 1208 EP - 18 JF - European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology JO - Eur Neuropsychopharmacol VL - 23 IS - 10 N2 - 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 70 mg/day), OROS-MPH (18, 36, or 54 mg/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 was -13.0 (95% CI: -15.9 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. SN - 1873-7862 UR - https://www.unboundmedicine.com/medline/citation/23332456/European_randomized_phase_3_study_of_lisdexamfetamine_dimesylate_in_children_and_adolescents_with_attention_deficit/hyperactivity_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0924-977X(12)00324-0 DB - PRIME DP - Unbound Medicine ER -