Clinical trial NCT00763971: Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
Official title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 336
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


Eligibility criteria: Inclusion Criteria:

1. Subject is a male or female aged 6-17 years inclusive at the time of consent.
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:

1. Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. One course must have been a long-acting formulation.
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).

Primary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
timeFrame: Baseline and up to 7 weeks
Secondary outcomes:
measure: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
timeFrame: Up to 7 weeks
measure: Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks
timeFrame: Baseline and up to 7 weeks
measure: Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks
timeFrame: Baseline and up to 7 weeks
measure: Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks
timeFrame: Baseline and up to 7 weeks
measure: Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks
timeFrame: Baseline and up to 7 weeks
measure: Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks
timeFrame: Baseline and up to 7 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Hoboken
country: Belgium
facility: ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken
state: Antwerp
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185
state: East Flanders
city: Leuven
country: Belgium
facility: Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003
city: Nice
country: France
facility: Hospital Archet 2
state: Cedex 03
city: Paris
country: France
facility: Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent
state: Ile-De-France
city: Bordeaux Cédex
country: France
facility: Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent
city: Montpellier Cedex 05
country: France
facility: Hôpital Gui de Chauliac, 80, avenue Augustin Fliche
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5
state: Baden Wuttemburg
city: Bamberg
country: Germany
facility: Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6
state: Bayern
city: Würzburg
country: Germany
facility: Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10
state: Bayern
city: Würzburg
country: Germany
facility: Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie
state: Bayern
city: Marburg
country: Germany
facility: Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4
state: Hessen
city: Göttingen
country: Germany
facility: Universitat Gottingen
state: Niedersachsen
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universitat Freiburg
city: Fulda
country: Germany
facility: Praxis Dr. Walter Robert Otto
city: Hagen
country: Germany
facility: Praxis Dr. Wolff
city: Hamburg
country: Germany
facility: Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse
city: Hamburg
country: Germany
facility: Praxis für Neuropädiatrie, Schomburgstrasse 120
city: Budapest
country: Hungary
facility: Vadaskert Kórház és Szakambulancia
city: Gyula
country: Hungary
facility: Pándy Kálmán Kórház
city: Pécs
country: Hungary
facility: Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
city: Cagliari
country: Italy
facility: Università degli Studi di Cagliari, Dipartimento di Neuroscienze
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Napoli
country: Italy
facility: Azienda Ospedaliera della 2 Universita di Napoli
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny
state: Mazowieckie
city: Gdansk
country: Poland
facility: Gdanski Uniwersytet Medyczna w Gdansku
state: Pomorskie
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Dèu
state: Barcelona
city: Torremolinos
country: Spain
facility: Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n
state: Malaga
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica
state: Navarra
city: San Cristóbal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias C/Ofra
state: Santa Cruz De Tenerife
city: Badajoz
country: Spain
facility: Complejo Hospitalario Universitario de Badajoz
city: Barcelona
country: Spain
facility: Mutua de Terrassa
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal, Servicio de psiquiatría
city: Mariestad
country: Sweden
facility: Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12
state: Vastergotland
city: Goteborg
country: Sweden
facility: Drottning Silvias Barnsjukhus
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9
city: Basildon
country: United Kingdom
facility: Basildon Hospital, Child Developement Centre, Nethermayne
state: Essex
city: Southend-on-Sea
country: United Kingdom
facility: Lighthouse Child Development Centre, Snakes Lane
state: Essex
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital, Paediatric Unit, Hayfield Road
state: Fife, Scotland
city: Dundee
country: United Kingdom
facility: Tayside Childrens Hospital, Clinical Research Facility, Level 4
state: Scotland
city: Sheffield
country: United Kingdom
facility: Ryegate Children's Centre, Tapton Crescent Road
state: Yorkshire
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.