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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01081145
Other study ID # SPD503-315
Secondary ID 2009-018161-12
Status Completed
Phase Phase 3
First received
Last updated
Start date May 11, 2010
Est. completion date June 3, 2013

Study information

Verified date June 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.


Recruitment information / eligibility

Status Completed
Enrollment 528
Est. completion date June 3, 2013
Est. primary completion date June 3, 2013
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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) Guideline E6 (1996) and applicable regulations before completing any study-related procedures at Screening/Visit 1. 3. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD, combined subtype, hyperactive/impulsive subtype, 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 Enrolment/Visit 2. 5. Subject has a minimum CGI-S score of 4 at Enrolment/Visit 2. 6. Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator. 7. Subject and parent/LAR understand, are willing, able, and likely to fully comply with the study requirements, procedures, and restrictions defined in this protocol. 8. Subject is able to swallow intact tablets. 9. 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 Screening/Visit 1 and a negative urine pregnancy test at Enrolment/Visit 2 and agree to comply with any applicable contraceptive requirements of the protocol. 10. Subject has a supine and standing BP measurement within the 95th percentile for age, gender, and height. Exclusion Criteria: 1. Subject has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, comorbid psychiatric diagnosis, except oppositional defiant disorder (ODD), 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 SPD503 treatment or confound efficacy or safety assessments. 2. Subject has any condition or illness including 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. 3. Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre syncope, or clinically significant bradycardia. 4. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension. 5. Subject has clinically significant ECG findings as judged by the Investigator with consideration of the central ECG laboratory's interpretation. 6. Current use of any prohibited medication or other medications, including herbal supplements, that affect BP or heart rate or that have 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 [i.e., antihistamines]) in violation of the protocol specified washout criteria at Enrolment/Visit 2. 7. Subject has used an investigational product within 30 days prior to Enrolment/Visit 2. 8. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts. Significantly overweight is defined as a BMI >95th percentile. 9. Children aged 6-12 years with a body weight of <25kg or adolescents aged 13-17 years with a body weight of <34kg or >91kg at Screening/Visit 1. 10. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503. 11. Clinically important abnormality on drug and alcohol screen (excluding the subject's current ADHD stimulant if applicable) at Screening/Visit 1. 12. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV-TR (with the exception of nicotine) within the last 6 months. 13. Subject is female and is pregnant or currently lactating. 14. Subject failed screening or was previously enrolled in this study. 15. 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 (see protocol Section 7.2.4.2 for additional guidance). 16. History of failure to respond to an adequate trial of an alpha 2-agonist for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the Investigator). 17. 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). 18. Subject has another member of the same household currently participating in this study.

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Drug:
Extended-release Guanfacine Hydrochloride
The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight.
Other:
Placebo
Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.

Locations

Country Name City State
Belgium Cliniques Universitaires Saint Luc Brussels
Belgium Universitair Ziekenhuis Gent Ghent Oost-vlaanderen
Belgium Huisartspraktijk Jaak Mortelmans Ham
Belgium Ziekenhuis Netwerk Antwerpen Hoboken Antwerpen
Belgium Universitair Ziekenhuis Brussel Jette Brussels
Belgium Centre de référence Neuropédiatrique Multidisciplinaire Namur
Belgium Psypluriel Uccle
Belgium Ziekenhuis Inkendaal Koninklijke Instelling v.z.w. Vlezenbeek
Canada JPM van Stralen Medicine Professional Corporation Ottawa Ontario
Canada Royal University Hospital Saskatoon Saskatchewan
Canada Children's and Women's Health Centre of British Columbia Vancouver British Columbia
Canada ADHD Clinic/The Kid's Clinic Whitby Ontario
France Centre Hospitalier Universitaire d'Amiens, Hôpital Nord Amiens Cedex Picardie
France Centre Hospitalier Universitaire Bocage-Hôpital d'enfants Dijon Cedex
France Hôpital Gui de Chauliac Montpellier Cedex 5 Languedoc-roussillon
France Hopitaux Pediatriques de Nice - CHI Lenval Nice Provcence Alpes Cote D'Azur
France Hopital Robert Debre Centre pediatrique des pathologies du sommeil Paris
France Hopital Robert-Debre' Paris cedex 19
France Centre Hospitalier de Rouffach Rouffach Alsace
France Hopital Gatien de Clocheville CHU de Tours Tours
Germany Emovis GmbH Berlin
Germany Sozialpsychiatrisches Centrum Dr. med. Ralph Meyers Dorsten Nordrhein-westfalen
Germany Universitatsklinikum Freiburg Freiburg
Germany Friedrich-Schiller-Universitat Jena Jena Thuringen
Germany Klinikum der Johannes-Gutenberg-Universität Mainz Mainz Rheinland-pfalz
Germany Praxis Dr. med. Dipl. Psych. Anton Lindermüller München Bayern
Germany Center for Pediatric Clinical Studies Tübingen Baden-wuerttemberg
Germany Universitätsklinik Ulm Ulm Baden-wuerttemberg
Germany Medizinisches Studienzentrum Wurzburg Wurzburg Bayern
Italy IRCCS Fondazione Stella Maris Calambrone Pisa
Italy Azienda Ospedaliero-Universitaria Policlinico-Vittorio Catania
Italy Azienda Osp. Fatebenefratelli - Polo Territoriale UONPIA Milano
Italy Azienda ULSS 16 Padova Padova
Italy Azienda Ospedaliera "Guido Salvini" Rho Milan
Italy Drottning Silvias Barnsjukhus Roma
Italy Università Cattolica del Sacro Cuore Roma
Netherlands FlevoResearch Almere Flevoland
Netherlands Academisch Ziekenhuis Maastricht Maastricht Limburg
Netherlands Mondriaan Zorggroep Heerlen, Kinder en Jeugdp sychiatrie Maastricht
Spain Hospital Fundacion Alcorcon Alcorcon Madrid
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Policlínica Guipuzkoa Donostia-San Sebastián Guipuzcoa
Spain Hospital Infanta Leonor Madrid
Spain Hospital Son Llàtzer, Laboratorio de Neurociencias IUNICS Palma Islas Baleares
Spain Clínica Universitaria de Navarra Pamplona Navarra
Spain Instituto Valenciano de Neurología Pediatrica Valencia
Sweden Barn och Ungdomsmedicin klinik Mölnlycke Mölnlycke
United Kingdom Thurrock Community Hospital Grays
United Kingdom Royal Liverpool University Hospital Liverpool
United Kingdom Norfolk Community Health and Care NHS Trust Norwich England
United Kingdom Centenary House Child and Adolescent Mental Health Services Sheffield England
United Kingdom Ryegate Children's Centre Sheffield England
United Kingdom Lister Hospital Stevenage
United Kingdom Queen Elizabeth II Hospital Welwyn Garden City England
United States FutureSearch Clinical Trials Austin Texas
United States Florida Clinical Research Center, LLC Bradenton Florida
United States Ohio State University, Nisonger Center Columbus Ohio
United States Harmonex Neuroscience Research Dothan Alabama
United States Triangle Neuropsychiatry, PLLC Durham North Carolina
United States Sarkis Clinical Trials Gainesville Florida
United States Amedica Research Institute, Inc. Hialeah Florida
United States Goldpoint Clinical Research, LLC Indianapolis Indiana
United States Clinical Neuroscience Solutions, Inc. Jacksonville Florida
United States Eastside Therapeutic Resource Kirkland Washington
United States Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada
United States Clinical Study Centers, LLC Little Rock Arkansas
United States Florida Clinical Research Center, LLC Maitland Florida
United States AMR-Baber Research Inc. Naperville Illinois
United States Louisiana Research Associates, Inc. New Orleans Louisiana
United States Mount Sinai School of Medicine New York New York
United States IPS Research Company Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Clinical Neuroscience Solutions, Inc. Orlando Florida
United States CRI Worldwide, LLC Philadelphia Pennsylvania
United States Alliance Research Group, LLC Richmond Virginia
United States Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) Salem Oregon
United States Delmarva Family Resources Salisbury Maryland
United States ADHD Clinic of San Antonio San Antonio Texas
United States Psychiatric Centers at San Diego, Feighner Research San Diego California
United States Encompass Clinical Research - North Coast Spring Valley California
United States Elite Clinical Trials, Inc. Wildomar California

Sponsors (1)

Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis. 26 weeks
Secondary Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis. 26 weeks
Secondary Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF) 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. Baseline and week 26
Secondary Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill) 26 weeks
Secondary Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. Baseline and week 26
Secondary Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. 26 weeks
Secondary Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. 26 weeks
Secondary Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF 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. Baseline and 13 weeks
Secondary Percentage of Responders in the Open-Label Phase - LOCF Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of >=30% and a CGI-S score of 1 or 2. 13 weeks
Secondary Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. 13 weeks
Secondary Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill) 13 weeks
Secondary Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. Baseline and week 13
Secondary HUI 2/3 Scores During the Open-Label Phase - LOCF HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. 13 weeks
Secondary Columbia-Suicide Severity Rating Scale During Open-Label Phase C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. 13 weeks
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