Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
NCT ID: NCT00763971
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
336 participants
INTERVENTIONAL
2008-11-17
2011-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lisdexamfetamine Dimesylate (LDX)
Overencapsulated LDX 30, 50, or 70mg
Lisdexamfetamine Dimesylate (LDX)
30, 50 or 70mg capsule once per day (Overencapsulated)
Methylphenidate Hydrochloride
Overencapsulated Concerta 18, 36, or 54mg
Methylphenidate Hydrochloride
18, 36, or 54mg tablet one per day (Overencapsulated)
Placebo
Overencapsulated Placebo
Placebo
Placebo capsule once per day (Overencapsulated)
Interventions
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Lisdexamfetamine Dimesylate (LDX)
30, 50 or 70mg capsule once per day (Overencapsulated)
Methylphenidate Hydrochloride
18, 36, or 54mg tablet one per day (Overencapsulated)
Placebo
Placebo capsule once per day (Overencapsulated)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
3. Subject must have a Baseline ADHD-RS-IV total score ≥28.
4. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
5. Subject is able to swallow a capsule.
Exclusion Criteria
2. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
3. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
4. Subject has glaucoma.
5. Subject weighs less than 22.7kg (50lbs).
6. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI \>97th percentile for this study.
7. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
8. Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
9. Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
10. Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
12. Subject is well controlled on their current ADHD medication with acceptable tolerability.
13. Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
6 Years
17 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken
Hoboken, Antwerp, Belgium
Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185
Ghent, East Flanders, Belgium
Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003
Leuven, , Belgium
Hospital Archet 2
Nice, Cedex 03, France
Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent
Bordeaux Cédex, , France
Hôpital Gui de Chauliac, 80, avenue Augustin Fliche
Montpellier, , France
Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent
Paris, Île-de-France Region, France
Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5
Mannheim, Baden Wuttemburg, Germany
Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6
Bamberg, Bavaria, Germany
Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10
Würzburg, Bavaria, Germany
Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie
Würzburg, Bavaria, Germany
Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4
Marburg, Hesse, Germany
Universitat Gottingen
Göttingen, Lower Saxony, Germany
Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,
Mainz, Rhineland-Palatinate, Germany
Universitätsmedizin Berlin
Berlin, , Germany
Albert-Ludwigs-Universitat Freiburg
Freiburg im Breisgau, , Germany
Praxis Dr. Walter Robert Otto
Fulda, , Germany
Praxis Dr. Wolff
Hagen, , Germany
Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse
Hamburg, , Germany
Praxis für Neuropädiatrie, Schomburgstrasse 120
Hamburg, , Germany
Vadaskert Kórház és Szakambulancia
Budapest, , Hungary
Pándy Kálmán Kórház
Gyula, , Hungary
Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó
Pécs, , Hungary
Szegedi Tudományegyetem
Szeged, , Hungary
Università degli Studi di Cagliari, Dipartimento di Neuroscienze
Cagliari, , Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
Azienda Ospedaliera della 2 Universita di Napoli
Napoli, , Italy
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10
Nijmegen, , Netherlands
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Wojewodzki Osrodek Lecznictwa Psychiatrycznego
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, Masovian Voivodeship, Poland
Gdanski Uniwersytet Medyczna w Gdansku
Gdansk, Pomeranian Voivodeship, Poland
Hospital Sant Joan de Dèu
Esplugues de Llobregat, Barcelona, Spain
Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n
Torremolinos, Malaga, Spain
Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica
Pamplona, Navarre, Spain
Hospital Universitario de Canarias C/Ofra
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Complejo Hospitalario Universitario de Badajoz
Badajoz, , Spain
Mutua de Terrassa
Barcelona, , Spain
Hospital Ramón y Cajal, Servicio de psiquiatría
Madrid, , Spain
Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12
Mariestad, Vastergotland, Sweden
Drottning Silvias Barnsjukhus
Gothenburg, , Sweden
Astrid Lindgren Children's Hospital, Karolinska University Hospital
Stockholm, , Sweden
Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9
Stockholm, , Sweden
Basildon Hospital, Child Developement Centre, Nethermayne
Basildon, Essex, United Kingdom
Lighthouse Child Development Centre, Snakes Lane
Southend-on-Sea, Essex, United Kingdom
Victoria Hospital, Paediatric Unit, Hayfield Road
Kirkcaldy, Fife, Scotland, United Kingdom
Tayside Childrens Hospital, Clinical Research Facility, Level 4
Dundee, Scotland, United Kingdom
Ryegate Children's Centre, Tapton Crescent Road
Sheffield, Yorkshire, United Kingdom
Countries
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References
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Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.
Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.
Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.
Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.
Related Links
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FDA recal information
Other Identifiers
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2008-000679-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-325
Identifier Type: -
Identifier Source: org_study_id
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