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Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD

Intervention: Extended-release Guanfacine HCl (Intuniv, SPD503) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Brigitte Robertson, MD, Study Director, Affiliation: Shire Inc,

Summary

For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

Clinical Details

Official title: A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Systolic Blood Pressure

Diastolic Blood Pressure

Pulse Rate

Height

Weight

Electrocardiogram Results (QRS interval)

Electrocardiogram Results (QT interval)

Secondary outcome:

Attention deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV)

Clinical Global Impression - Severity of Illness (CGI-S) Scale

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is satisfied with their current ADHD medication. 2. Subject satisfied all entry criteria for the antecedent study (SPD503 315 or SPD503-316). 3. Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or <9 years of age and is post-menarchal, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol. 4. 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) Guideline E6 and applicable regulations, before completing any study-related procedures. 5. Subject and parent/LAR are willing, able, and likely to fully comply with all the testing and requirements defined in this protocol, including oversight of dosing. Specifically, the parent/LAR must be available upon awakening, to dispense the dose of investigational product for the duration of the study. 6. Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, sex, and height. 7. Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator. 8. Subject is able to swallow intact tablets. Exclusion Criteria: 1. Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis (except oppositional defiant disorder), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, 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 confound efficacy or safety assessments. The

Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime

version (K-SADS-PL) rating from the antecedent study should be reviewed to confirm diagnosis, if necessary. 2. Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocol non-adherence, subject non-compliance, an AE, SAE, or withdrawal by subject. 3. Subject experienced any clinically significant AE in their prior SPD503 study (SPD503-315 or SPD503 316) that, in the opinion of the Investigator, would preclude exposure to SPD503. 4. Clinically important abnormality on urine drug and/or alcohol screen at the Screening Visit (Visit 1). 5. Subject has taken any investigational product as follows: last dose of investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2); investigational product in Study SPD503 316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2). 6. Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age sex-specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile. 7. Children aged 6 12 years with a body weight of less than 25. 0kg or adolescents aged 13 years and older with a body weight of less than 34. 0kg at the Screening Visit (Visit 1). 8. Subject has any condition or illness including clinically significant abnormal laboratory values at the Screening Visit (Visit 1) which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study. 9. 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 suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. 10. Subject has clinically significant ECG findings, as judged by the Investigator with consideration of the central ECG laboratory's interpretation, at the Baseline Visit (Visit 2). 11. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in SPD503. 12. Subject has a history of alcohol or other substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text RevisionÃ’ (DSM-IV-TRÃ’; with the exception of nicotine) within the last 6 months. 13. 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. 14. Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically significant heart block), exercise related cardiac events including syncope and pre syncope, or clinically significant bradycardia. 15. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension. 16. Current use of any prohibited medication or other medications, including herbal supplements, that affect BP or heart rate or 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 the Baseline Visit (Visit 2). 17. Subject has a medical condition, other than ADHD, that requires treatment with medications that have CNS effects and/or affect performance. 18. Subject is female and is pregnant or currently lactating. 19. Subject failed screening or was previously enrolled in this study.

Locations and Contacts

Medizinische Universitat Graz Univ fur Kinder, Graz 6036, Austria

Institut fur Psychosomatik, Wien 1010, Austria

Universitaire Kinder-end Jeugdpsychatrie, Hoboken 2660, Belgium

Centre de Reference Neuropediatrique Multidisciplinaire, Namur 5000, Belgium

Huisartspraktijk Jaak Mortelmans, Oostham 3845, Belgium

Zlekenhuis Inkendaal Koninklijke Instelling v.z.w., Vlezenbeek 1602, Belgium

Centre Hospitalier Charles Perrens, Bordeaux Cedex 33076, France

Hopital Gui de Chauliac, Montpellier 34295, France

Dr. med. Andreas Mahler, Achim 28632, Germany

Emovis GmbH, Berlin 10629, Germany

Sozialpsychitrisches Zentrum, Dorsten 46282, Germany

Klinik und Poliklinik fur Kinder-und Jugendpsychiatrie un psychotherapie, Dresden 01307, Germany

Dr. med Walter Robert Otto, Fulda 36037, Germany

Dr. med. Christian Wolff, Hagen 58093, Germany

Dr. med Friedrich Kaiser, Hamburg 22415, Germany

Institut fur Ganzheitliche Medizin und Wissenschaft GmbH, Huttenberg 35625, Germany

Friedrich Schiller Universitat Jena Klinik fur Kinder und Jugendpsychiatrie, Jena 07743, Germany

Universitatsmedizin der Johannes-Gutenberg-Universitat, Mainz 55131, Germany

Kinder-und Jugendpsychiatrische Praxis, Munchen 81241, Germany

Somni bene GmbH Institut fur Medizinische Forschung und Schlatmedizin, Schwerin 19053, Germany

Universitatsklinik Ulm, Ulm 89075, Germany

Azienda Ospedaliero-Universitaria Policlinico-Vittorio, Catania 95123, Italy

Azienda Ospedallera Fatebenefratelli, Milano 20129, Italy

Azienda Ospedallera G Salvini - Ospedale Di Circolo de RHO, Milano 20017, Italy

U.O di Neuropsichiatria Infantile, Padova 35143, Italy

IRCCS Fondazione Stella Maris, Pisa 56018, Italy

Ospedale Policlinico GB Rossi, Verona 37134, Italy

Flevo Research, Almere 1311 RL, Netherlands

Mondriaan Zorggroep, Heerlen 6419 XZ, Netherlands

Centrum Badari Klinicznych House Sp. z.o.o., Gdansk 80-546, Poland

NZOZ Gdanskie Centrum Zdrowia, Gdansk 80-542, Poland

Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Torum 87-100, Poland

Indywidualna Specjalisyczna Praktyka Lekarska, Torun 87-100, Poland

Contrum Neurospychiatrii Neuromed, Wroclaw 54-2353, Poland

Spitalul Clinic de Psihiatrie, Bucuresti 041914, Romania

Spitalul Clinic de Psihiatrie Socoia, Iasi 700282, Romania

Hospital Universitani Vall d'Hebron, Barcelona 08035, Spain

Hospital Infanta Leonor, Servicio de Psiquiatria, Madrid 28031, Spain

Hospital Son Llatzer, Palma de Mallorca 07198, Spain

Unidad de Salud Mental Infanto Juvenil, Santander 39011, Spain

Instituto Valenciano de Neurologia Pediatrica, Valencia 46010, Spain

Drottning Silvias Barnsjukhus, Goteborg SE-411 18, Sweden

Regional Clinical Psychiatric Hospital, Donetsk 83008, Ukraine

Institute of Health Care for Children and Teenagers, Kharkiv, Ukraine

Institute of Neurology, Psychiatry and Narcology, Kharkov 61068, Ukraine

Lviv Regional Clinical Psychiatric Hospital, Lviv 79021, Ukraine

Odesa Regional Psychoneurological Dispensary, Odesa 65084, Ukraine

Poltava Regional Clinical Psychiatric Hospital, Poltava 36013, Ukraine

Vinnitsya regional psychoneurological hospital, Vinnytsia 21005, Ukraine

The Children's Centre, Norwich NR4 7PA, United Kingdom

Centenary House Child and Adolescent Mental Health Services, Sheffield S6 3BR, United Kingdom

Ryegate Children's Centre, Sheffield S10 5DD, United Kingdom

Hospital Mutua de Terrassa, Terrassa, Barcelona 08221, Spain

Our Lady's Children's Hospital, Crumlin, Dublin 12, Ireland

Queen Elizabeth II Hospital - Howlands, Garden City, Herfordshire AL7 4HQ, United Kingdom

Lister Hospital, Stevenage, Herfordshire, United Kingdom

Alder Hey Children's NHS Foundation Trust, West Derby, Liverpool L12 2AP, United Kingdom

Hospital Fundacion Alcorcon, Calle, Madrid 28922, Spain

Centre Hospitalier Universitaire Amiens, Amiens Cedex, Picardie 80054, France

Spitalul Clinic de Urgenta pentru Copli, Timisoara, Timis 300239, Romania

Additional Information

Starting date: March 2012
Last updated: June 6, 2014

Page last updated: August 23, 2015

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