For children and adolescents, how does SPD503 compare to placebo for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD).
Inclusion Criteria:
1. Male or female, aged 6 17 years at the time of consent/assent at Screening (Visit 1).
2. Subject's parent or legally authorised representative (LAR) must provide signature of
informed consent, and there must be documentation of assent (if applicable) by the
subject indicating that the subject is aware of the investigational nature of the
study and the required procedures and restrictions in accordance with the
International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance
E6, and applicable regulations before completing any study related procedures at
Screening (Visit 1).
3. Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition,
Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, combined
sub-type, hyperactive/impulsive sub-type, or inattentive sub-type based on a detailed
psychiatric evaluation using the Kiddie Schedule for Affective Disorders and
Schizophrenia - Present and Lifetime version (K-SADS-PL).
4. Subject has a minimum ADHD-RS-IV total score of 32 at Baseline (Visit 2).
5. Subject has a minimum CGI-S score of 4 at Baseline (Visit 2).
6. Subject is functioning at an age-appropriate level intellectually, as judged by the
Investigator.
7. Subject and parent/LAR understand, are willing, able, and likely to fully comply with
the study procedures and restrictions defined in this protocol.
8. Subject is able to swallow intact tablets and capsules.
9. Subject who is a female of child-bearing potential (FOCP), defined as greater than or
equal to 9 years of age or <9 years of age and is menarchal, must have a negative
serum beta Human Chorionic Gonadotropin (hCG) pregnancy test at Screening (Visit 1)
and a negative urine pregnancy test at Baseline (Visit 2) and agree to comply with
any applicable contraceptive requirements of the protocol.
10. Subject has supine and standing blood pressure (BP) measurement within the 95th
percentile for age, sex, and height
Exclusion Criteria:
1. Subject has a current, controlled (requiring a prohibited medication or behavioural
modification program) or uncontrolled, co-morbid psychiatric diagnosis [except
oppositional defiant disorder (ODD)], including any severe co-morbid Axis II
disorders or severe Axis I disorders such as post traumatic stress disorder (PTSD),
bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive
disorder (OCD), substance abuse disorder, or other symptomatic manifestations or
lifetime history of bipolar illness, psychosis or conduct disorder that, in the
opinion of the Investigator, contraindicate treatment with SPD503 or STRATTERA or
confound efficacy or safety assessments.
2. Subject is well-controlled on their current medication, with acceptable tolerability,
and the parent/caregiver does not object to the current medication.
3. Subject has any condition or illness including a clinically significant abnormal
Screening (Visit 1) laboratory values which, in the opinion of the Investigator,
represents an inappropriate risk to the subject and/or could confound the
interpretation of the study. Mild stable asthma treated without the use of beta-2
agonist is not exclusionary.
4. Subject has a known history or presence of structural cardiac abnormalities,
cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities,
syncope, tachycardia, cardiac conduction problems (eg, clinically significant heart
block or QT interval prolongation), exercise-related cardiac events including syncope
and pre syncope, or clinically significant bradycardia.
5. Subject has a known family history of sudden cardiac death, ventricular arrhythmia,
or QT prolongation.
6. Subjects with orthostatic hypotension or a known history of hypertension.
7. Subject has glaucoma.
8. Subject has clinically significant ECG findings as judged by the Investigator with
consideration of the central ECG laboratory's interpretation.
9. Subject has a history of a seizure disorder (other than a single childhood febrile
seizure occurring before the age of 3 years) or the presence of a serious tic
disorder including Tourette's Syndrome.
10. Current use of any prohibited medication or other medications, including monoamine
oxidase inhibitors, herbal supplements, that affect BP or heart rate potent CYP2D6
inhibitors, medications known to prolong the QT/QTc interval, medications that lower
seizure threshold, pressor agents, beta-2 agonists, medications that affect
noradrenaline, medications that have central nervous system (CNS) effects or affect
cognitive performance, such as sedating antihistamines and decongestant
sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use
of sedating medications [ie, antihistamines]) in violation of the protocol specified
washout criteria at Baseline (Visit 2).
11. Subject has a history of alcohol or other substance abuse or dependence, as defined
by DSM-IV (with the exception of nicotine) within the last 6 months.
12. Subject has taken another investigational product within 30 days prior to Baseline
(Visit 2).
13. Subject is significantly overweight based on Center for Disease Control and
Prevention Body Mass Index (BMI)-for-age gender specific charts at the Screening
(Visit 1). Significantly overweight is defined as a BMI >95th percentile.
14. Children aged 6 12 years with a body weight of less than 25kg or adolescents aged 13
17 years with a body weight of less than 34kg or greater than 91kg at Screening
(Visit 1).
15. Subject has a known or suspected allergy, hypersensitivity, or clinically significant
intolerance to guanfacine hydrochloride or atomoxetine hydrochloride, or any
components found in SPD503 or STRATTERA.
16. Clinically important abnormality on drug and alcohol screen (excluding the subject's
current ADHD stimulant if applicable) at Screening (Visit 1)
17. Subject is female and is pregnant or currently lactating.
18. Subject failed screening or was previously enrolled in this study.
19. Subject is currently considered a suicide risk in the opinion of the Investigator,
has previously made a suicide attempt, or has a prior history of, or is currently
demonstrating active suicide ideation. Subjects with intermittent passive suicidal
ideation are not necessarily excluded based on the assessment of the Investigator.
20. History of failure to respond to an adequate trial of an α2-agonist or atomoxetine
hydrochloride for the treatment of ADHD (consisting of an appropriate dose and
adequate duration of therapy in the opinion of the investigator).
21. Subjects with renal or hepatic insufficiency.
Medizinische Universitat Graz-Universitaklinik fur Kinder-und Jugendheilkunde, Graz 8036, Austria; Recruiting
Wolfgang Kaschnitz, Principal Investigator
Institut für Psychosomatik, Wien 1010, Austria; Recruiting
Margot Schmitz, Principal Investigator
Centre Hospitalier Charles Perens - Service de Psychiatrie de l'Enfant et de l'Adolescent, Bordeaux 33076, France; Recruiting
Manuel Bouvard, Principal Investigator
Centre Hospitalier des Pyrenees, Chartres 28018, France; Recruiting
Elsa Excoffier, Principal Investigator
Centre Hospitalier de Versailles, Le Chesnay 78157, France; Withdrawn
Praxis Dr. Andreas Mahler, Achim 28832, Germany; Recruiting
Andreas Mahler, Principal Investigator
AD/HS-Zentrum, Berlin 80637, Germany; Withdrawn
Emovis GmbH, Berlin 10629, Germany; Recruiting
Bettina Bergtholdt, Principal Investigator
Vestische Kinder und Jugendklinik Datteln, Datteln 45711, Germany; Withdrawn
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden, Dresden 01307, Germany; Recruiting
Veit Roessner, Principal Investigator
Praxisgemeinschaft Drs. Willem Geraets/Gabriele Lucassen, Dusseldorf 40215, Germany; Recruiting
Willem Geraets, Principal Investigator
Praxis Dr. Walter Robert Otto, Fulda 36037, Germany; Recruiting
Walter Otto, Principal Investigator
Praxis Dr. Friedrich Kaiser un Ingrid Marinesse, Hamburg 22415, Germany; Recruiting
Friedrich Kaiser, Principal Investigator
Institut fur Ganzheitiche Medzin und Wissenschaft GmbH, Huttenberg 35625, Germany; Recruiting
Rudiger Schellenberg, Principal Investigator
Klinikum der Johannes-Guttenberg-Universitat Mainz, Mainz 55131, Germany; Recruiting
Michael Huss, Principal Investigator
Zentralinstitut fur Seelische Geseundheit Mannheim Klinik for Psuchiatrie und Psychotherapie des Kindes, Mannheim 68159, Germany; Recruiting
Ralf Dittman, Prof Dr med, Principal Investigator
Somni Bene GmbH - Institut für Medizinische Forschung und Schlafmedizin, Schwerin, Germany; Recruiting
Heike Benes, Principal Investigator
Department of Child and Adolescent Psychiatry, Dublin 12, Ireland; Recruiting
Fiona McNicholas, Principal Investigator
IRCCS Eugenio Medea - Associazione La Nostra Famiglia, Brindisi 72100, Italy; Recruiting
Angelo Massagli, Principal Investigator
IRCCS "Istituto Neurologico C. Mondino", Pavia 27100, Italy; Withdrawn
IRCCS Stella Maris - U.O. Psichiatria e Psicofarmacologia Eta' Evolutiva, Pisa 56018, Italy; Recruiting
Gabriele Masi, Principal Investigator
Azienda Ospedaliera "Guido Salvini", Rho 20017, Italy; Withdrawn
Università Cattolica del Sacro Cuore, Rome 00168, Italy; Recruiting
Maria G Torrioli, Principal Investigator
Ospedale Policlinico G.B.Rossi - Azienda Ospedaliera Universitaria Integrata Verona, Verona 37134, Italy; Recruiting
Bernardo Dalla Bernardina, Principal Investigator
NZOZ Gdan Skie Centrum Zdrowia, Gdansk 80-542, Poland; Recruiting
Bozena Pietraszczyk-Kedziora, Principal Investigator
Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Miroslaw Dabkowski, Torun 87-100, Poland; Recruiting
Miroslaw Dabkowski, Principal Investigator
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Bucuresti, Romania; Recruiting
Iuliana Dobrescu, Principal Investigator
Spitalul Clinic de Psihiatrie Socola, Iasi, Romania; Recruiting
Carmen Lupusoru, Principal Investigator
Hospital Universitari Vall d'Hebron, Barcelona 08035, Spain; Recruiting
Josep Ramos-Quirogo, Principal Investigator
Policlínica Guipuzkoa, Donostia-San Sebastián 20009, Spain; Recruiting
Joaquin Fuentes-Biggi, Principal Investigator
Hospital Marítimo, (USMI-J), Malaga 29620, Spain; Recruiting
Isabel Hernandez-Otero, Principal Investigator
Hospital de Dia Infantil y Juvenil Dr Diego Guigou y Costa, Santa Cruz de Tenerife 38003, Spain; Recruiting
Pedro Rodriguez-Hernandez, Principal Investigator
Hospital Universitario Marques de Valdecilla, Santander 39011, Spain; Recruiting
Beatriz Paya, Principal Investigator
Instituto Valenciano de Neurología Pediatrica, Valencia 46010, Spain; Recruiting
Fernando Mulas, Principal Investigator
Drottning Silvias Barnsjukhus, Goteborg 411 18, Sweden; Recruiting
Mats Johnson, Principal Investigator
Barn och Ungdomsmedicin klinik Mölnlycke, Mölnlycke 43530, Sweden; Recruiting
Mats Reimer, Principal Investigator
BUP mottagningen Varberg, Varberg 432 43, Sweden; Recruiting
Per-Olaf Andersson, Principal Investigator
Regional Clinical Psychiatric Hospital, Donetsk 83037, Ukraine; Recruiting
Volodymyr Abramov, Principal Investigator
Municipal Institution "Institute of healthcare for children and adolescences NAMNU, Kharkiv 61153, Ukraine; Recruiting
Tetyana Proskurina, Principal Investigator
Kherson Regional Psychiatric Hospital, Kherson 73488, Ukraine; Recruiting
Pavlo Palamarchuk, Principal Investigator
Lviv Regional Clinical Psychiatric Hospital, Lviv 79021, Ukraine; Recruiting
Oleksandr Filts, Principal Investigator
Odesa Regional Psychoneurological Dispensary, Outpatient Dept, Odesa 65084, Ukraine; Recruiting
Anatolli Voloshchuk, Principal Investigator
O.F. Maltsev Poltava Regional Psychiatric Hospital, Poltava 36000, Ukraine; Recruiting
Andrey Skrypnikov, Principal Investigator
Vinnytsia National Medical University - Vinnytsia Regional Psycho-Neurological Hospital, Vinnytsia 21005, Ukraine; Recruiting
S V Rymsha, Principal Investigator
Horsham Child and Adolescent Mental Health Services, Horsham, United Kingdom; Recruiting
Sanjay Jain, Principal Investigator
Newcastle General Hospital, Newcastle NE1 4LP, United Kingdom; Recruiting
Sethu Wariyar, Principal Investigator
5 Boroughs Partnership NHS Trust, Wigan WN2 2JA, United Kingdom; Recruiting
Sandeep Ranote, Principal Investigator
Mutua de Terrassa, Terrassa, Barcelona 08221, Spain; Recruiting
Amaia Hervas, Principal Investigator
Birmingham Children's Hospital NHS Foundation Trust, Moseley, Birmingham B13 8QE, United Kingdom; Recruiting
Rekha Joji, Principal Investigator
Psychiatric Centers at San Diego, Feighner Research, San Diego, California 92108, United States; Active, not recruiting
Spitalul Clinic de Urgenta Pentru Copii Cluj, Cluj Napoca, Cluj 400660, Romania; Recruiting
Viorel Lupu, Principal Investigator
Centrum Neuropsychiatrii Neuromed, Wroclaw, Dolnoslaskie 54-235, Poland; Recruiting
Halina Flisiak-Antonijczuk, Principal Investigator
Victoria Hospital, Kirkcaldy, Fife KY2 5AH, United Kingdom; Recruiting
Chris Steer, Principal Investigator
Florida Clinical Research Center, LLC, Maitland, Florida 32751, United States; Active, not recruiting
Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States; Active, not recruiting
Psychiatric Associates, Overland Park, Kansas 66211, United States; Active, not recruiting
Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Kharkov, Kharkiv 61068, Ukraine; Recruiting
Valerii Pidkorytov, Principal Investigator
Indywidualna Specjalistyczna Praktyka Lekarska Borys Gniot, Torun, Kujawsko-pomorskie 87-100, Poland; Recruiting
Borys Gniot, Principal Investigator
Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Warszawa, Mazowieckie 00-576, Poland; Recruiting
Tomasz Wolanczyk, Principal Investigator
Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States; Active, not recruiting
University of Nebraska Medical Center, Dept. of Psychiatry, Omaha, Nebraska 68198-5581, United States; Active, not recruiting
Praxis Dr. Wolff, Hagen, Nordrhein-Westfalen 58093, Germany; Recruiting
Christian Wolff, Principal Investigator
James Paget University Hospital NHS Trust, Great Yarmouth, Norfolk NR31 6SQ, United Kingdom; Recruiting
Lakshman Doddamani, Principal Investigator
Innovis Health, Fargo, North Dakota 58103, United States; Active, not recruiting
Dr Grazyna B. Jackiewicz, MD, Niagra Falls, Ontario L2E 6A4, Canada; Active, not recruiting
JPM Van Stralen Medicine Professional Corp., Ottowa, Ontario K2G 1W2, Canada; Active, not recruiting
Centre HospitalierUniversitaire d'Amiens, Hoptial Nord, Amiens Cedex, Picardie 80054, France; Recruiting
Patrick Berquin, Principal Investigator
Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk, Pomorskie 80-546, Poland; Recruiting
Anita Sumila, Principal Investigator
Ashurt Child and Family Centre, Ashurst, Southampton SO40 7AR, United Kingdom; Recruiting
Wai Chen, Principal Investigator
Clinical Neuroscience Solutions, Inc., Memphis, Tennessee 38119, United States; Active, not recruiting
Claghorn-Lesem Research Clinic, Houston, Texas 77008, United States; Active, not recruiting
R/D Clincial Research, Inc., Lake Jackson, Texas 77566, United States; Active, not recruiting
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu", Timisoara, Timis 300239, Romania; Recruiting
Liliana Nussbaum, Principal Investigator
NeuroScience Inc., Herndon, Virginia 20170, United States; Active, not recruiting
