Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

NCT00763971 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3252008-000679-90
• Study Type: interventional
• Target: 336
• Locations: 10 countries
• Sites: 49

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks

  The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.

  Baseline and up to 7 weeks

Secondary Outcomes (7)

• Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

  Up to 7 weeks

• Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks

  Baseline and up to 7 weeks

• Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks

  Baseline and up to 7 weeks

• 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

  Baseline and up to 7 weeks

• Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks

  Baseline and up to 7 weeks

Study Arms (3)

Lisdexamfetamine Dimesylate (LDX)

EXPERIMENTAL

Overencapsulated LDX 30, 50, or 70mg

Drug: Lisdexamfetamine Dimesylate (LDX)

Methylphenidate Hydrochloride

ACTIVE COMPARATOR

Overencapsulated Concerta 18, 36, or 54mg

Drug: Methylphenidate Hydrochloride

Placebo

PLACEBO COMPARATOR

Overencapsulated Placebo

Drug: Placebo

Interventions

Lisdexamfetamine Dimesylate (LDX) DRUG

30, 50 or 70mg capsule once per day (Overencapsulated)

Also known as: Vyvanse™

Lisdexamfetamine Dimesylate (LDX)

Methylphenidate Hydrochloride DRUG

18, 36, or 54mg tablet one per day (Overencapsulated)

Also known as: Concerta®, OROS MPH

Methylphenidate Hydrochloride

Placebo DRUG

Placebo capsule once per day (Overencapsulated)

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is a male or female aged 6-17 years inclusive at the time of consent.
• 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.
• Subject must have a Baseline ADHD-RS-IV total score ≥28.
• Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
• Subject is able to swallow a capsule.

You may not qualify if:

• 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.
• 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.
• Subject has glaucoma.
• Subject weighs less than 22.7kg (50lbs).
• 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.
• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
• Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
• 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.
• 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.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subject is well controlled on their current ADHD medication with acceptable tolerability.
• Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).

Sponsors & Collaborators

• Shire: lead

Study Sites (49)

ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken

Hoboken, Antwerp, 2660, Belgium

Location

Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185

Ghent, East Flanders, 9000, Belgium

Location

Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003

Leuven, 3000, Belgium

Location

Hospital Archet 2

Nice, Cedex 03, 6202, France

Location

Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent

Bordeaux Cédex, 33076, France

Location

Hôpital Gui de Chauliac, 80, avenue Augustin Fliche

Montpellier, 34295, France

Location

Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent

Paris, Île-de-France Region, 75019, France

Location

Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5

Mannheim, Baden Wuttemburg, 68159, Germany

Location

Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6

Bamberg, Bavaria, 96047, Germany

Location

Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10

Würzburg, Bavaria, 97070, Germany

Location

Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie

Würzburg, Bavaria, 97080, Germany

Location

Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4

Marburg, Hesse, 35039, Germany

Location

Universitat Gottingen

Göttingen, Lower Saxony, 37075, Germany

Location

Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Albert-Ludwigs-Universitat Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Praxis Dr. Walter Robert Otto

Fulda, 36037, Germany

Location

Praxis Dr. Wolff

Hagen, 58093, Germany

Location

Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse

Hamburg, 22415, Germany

Location

Praxis für Neuropädiatrie, Schomburgstrasse 120

Hamburg, 22767, Germany

Location

Vadaskert Kórház és Szakambulancia

Budapest, 1021, Hungary

Location

Pándy Kálmán Kórház

Gyula, 5700, Hungary

Location

Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

Pécs, 7632, Hungary

Location

Szegedi Tudományegyetem

Szeged, 6750, Hungary

Location

Università degli Studi di Cagliari, Dipartimento di Neuroscienze

Cagliari, 9124, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, 98125, Italy

Location

Azienda Ospedaliera della 2 Universita di Napoli

Napoli, 80131, Italy

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 HX, Netherlands

Location

Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10

Nijmegen, 6525 GC, Netherlands

Location

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

Wojewodzki Osrodek Lecznictwa Psychiatrycznego

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Samodzielny Publiczny Dzieciecy Szpital Kliniczny

Warsaw, Masovian Voivodeship, 00-576, Poland

Location

Gdanski Uniwersytet Medyczna w Gdansku

Gdansk, Pomeranian Voivodeship, 80-282, Poland

Location

Hospital Sant Joan de Dèu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n

Torremolinos, Malaga, 29630, Spain

Location

Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica

Pamplona, Navarre, 31080, Spain

Location

Hospital Universitario de Canarias C/Ofra

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Complejo Hospitalario Universitario de Badajoz

Badajoz, 6010, Spain

Location

Mutua de Terrassa

Barcelona, 8221, Spain

Location

Hospital Ramón y Cajal, Servicio de psiquiatría

Madrid, 28034, Spain

Location

Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12

Mariestad, Vastergotland, 54224, Sweden

Location

Drottning Silvias Barnsjukhus

Gothenburg, 41119, Sweden

Location

Astrid Lindgren Children's Hospital, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9

Stockholm, 435 30, Sweden

Location

Basildon Hospital, Child Developement Centre, Nethermayne

Basildon, Essex, SS16 5NL, United Kingdom

Location

Lighthouse Child Development Centre, Snakes Lane

Southend-on-Sea, Essex, SS2 6XT, United Kingdom

Location

Victoria Hospital, Paediatric Unit, Hayfield Road

Kirkcaldy, Fife, Scotland, KY2 5AH, United Kingdom

Location

Tayside Childrens Hospital, Clinical Research Facility, Level 4

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Ryegate Children's Centre, Tapton Crescent Road

Sheffield, Yorkshire, S10 5DD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 23332456 RESULT

• 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.

  PMID: 23708466 RESULT

• 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.

  PMID: 23893527 RESULT

• 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.

  PMID: 26409610 DERIVED

Related Links

• FDA recal information

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: November 17, 2008
• Primary Completion: March 16, 2011
• Study Completion: March 16, 2011
• Last Updated: June 14, 2021
• Results First Posted: March 22, 2012

Record last verified: 2021-06

Locations

GB (5); NL (2); BE (3); HU (4); ES (7); IT (3); PL (4); FR (4); SE (4); DE (13)