European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder
Copyright © 2012 Elsevier B.V. and ECNP. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2013 |
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| Erschienen: |
2013 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology - 23(2013), 10 vom: 01. Okt., Seite 1208-18 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Coghill, David [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 24.04.2014 Date Revised 10.03.2022 published: Print-Electronic ClinicalTrials.gov: NCT00763971 Citation Status MEDLINE |
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| doi: |
10.1016/j.euroneuro.2012.11.012 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM224296566 |
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| 245 | 1 | 0 | |a European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00763971 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2012 Elsevier B.V. and ECNP. All rights reserved. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Adolescent | |
| 650 | 4 | |a Attention deficit disorder with hyperactivity | |
| 650 | 4 | |a Central nervous system stimulants | |
| 650 | 4 | |a Child | |
| 650 | 4 | |a Lisdexamfetamine dimesylate | |
| 650 | 4 | |a Prodrugs | |
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| 650 | 7 | |a Methylphenidate |2 NLM | |
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| 650 | 7 | |a Lisdexamfetamine Dimesylate |2 NLM | |
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| 700 | 1 | |a Banaschewski, Tobias |e verfasserin |4 aut | |
| 700 | 1 | |a Lecendreux, Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Soutullo, Cesar |e verfasserin |4 aut | |
| 700 | 1 | |a Johnson, Mats |e verfasserin |4 aut | |
| 700 | 1 | |a Zuddas, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Anderson, Colleen |e verfasserin |4 aut | |
| 700 | 1 | |a Civil, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Higgins, Nicholas |e verfasserin |4 aut | |
| 700 | 1 | |a Lyne, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Squires, Liza |e verfasserin |4 aut | |
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