Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018161-12 | EudraCT Number |
Not provided
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Not provided
Not provided
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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.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-release Guanfacine HCl | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended-release Guanfacine Hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn.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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn.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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | United States | ||
| Clinical Study Centers, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26871297 | Derived | Newcorn JH, Harpin V, Huss M, Lyne A, Sikirica V, Johnson M, Ramos-Quiroga JA, van Stralen J, Dutray B, Sreckovic S, Bloomfield R, Robertson B. Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study. J Child Psychol Psychiatry. 2016 Jun;57(6):717-28. doi: 10.1111/jcpp.12492. Epub 2016 Feb 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Guanfacine Hydrochloride | Administered as a once-daily oral dose between 1-7mg/day depending on age and weight |
| FG001 | Placebo | Administered as a once-daily oral dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | 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. |
|
| 26 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Psychiatric Centers at San Diego, Feighner Research | San Diego | California | 92108 | United States |
| Encompass Clinical Research - North Coast | Spring Valley | California | 91978 | United States |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34208 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Amedica Research Institute, Inc. | Hialeah | Florida | 33013 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| AMR-Baber Research Inc. | Naperville | Illinois | 60563 | United States |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | United States |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | United States |
| Delmarva Family Resources | Salisbury | Maryland | 21801 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Triangle Neuropsychiatry, PLLC | Durham | North Carolina | 27707 | United States |
| Ohio State University, Nisonger Center | Columbus | Ohio | 43210 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) | Salem | Oregon | 97301 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Clinical Trials | Austin | Texas | 78756 | United States |
| ADHD Clinic of San Antonio | San Antonio | Texas | 78247 | United States |
| Alliance Research Group, LLC | Richmond | Virginia | 23230 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| Ziekenhuis Netwerk Antwerpen | Hoboken | Antwerpen | 2660 | Belgium |
| Universitair Ziekenhuis Brussel | Jette | Brussels Capital | 1090 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Oost-vlaanderen | 9000 | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Huisartspraktijk Jaak Mortelmans | Ham | 3945 | Belgium |
| Centre de référence Neuropédiatrique Multidisciplinaire | Namur | 5000 | Belgium |
| Psypluriel | Uccle | 1180 | Belgium |
| Ziekenhuis Inkendaal Koninklijke Instelling v.z.w. | Vlezenbeek | 1602 | Belgium |
| Children's and Women's Health Centre of British Columbia | Vancouver | British Columbia | V6H3N1 | Canada |
| JPM van Stralen Medicine Professional Corporation | Ottawa | Ontario | K2G1W2 | Canada |
| ADHD Clinic/The Kid's Clinic | Whitby | Ontario | L1N8M7 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N-OW8 | Canada |
| Centre Hospitalier de Rouffach | Rouffach | Alsace | 68250 | France |
| Hôpital Gui de Chauliac | Montpellier | Languedoc-roussillon | 34295 | France |
| Centre Hospitalier Universitaire d'Amiens, Hôpital Nord | Amiens | Picardie | 80054 | France |
| Hopitaux Pediatriques de Nice - CHI Lenval | Nice | Provcence Alpes Cote D'Azur | 06200 | France |
| Centre Hospitalier Universitaire Bocage-Hôpital d'enfants | Dijon | 21033 | France |
| Hopital Robert Debre Centre pediatrique des pathologies du sommeil | Paris | 75 015 | France |
| Hopital Robert-Debre' | Paris | 75935 | France |
| Hopital Gatien de Clocheville CHU de Tours | Tours | 37 000 | France |
| Center for Pediatric Clinical Studies | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitätsklinik Ulm | Ulm | Baden-Wurttemberg | 89075 | Germany |
| Praxis Dr. med. Dipl. Psych. Anton Lindermüller | München | Bavaria | 81241 | Germany |
| Medizinisches Studienzentrum Wurzburg | Würzburg | Bavaria | 97070 | Germany |
| Sozialpsychiatrisches Centrum Dr. med. Ralph Meyers | Dorsten | North Rhine-Westphalia | 46282 | Germany |
| Klinikum der Johannes-Gutenberg-Universität Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Friedrich-Schiller-Universitat Jena | Jena | Thuringia | 07743 | Germany |
| Emovis GmbH | Berlin | 10629 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79104 | Germany |
| Azienda Ospedaliera "Guido Salvini" | Rho | Milan | 20017 | Italy |
| IRCCS Fondazione Stella Maris | Calambrone | Pisa | 56018 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico-Vittorio | Catania | 95123 | Italy |
| Azienda Osp. Fatebenefratelli - Polo Territoriale UONPIA | Milan | 20129 | Italy |
| Azienda ULSS 16 Padova | Padova | 35143 | Italy |
| Drottning Silvias Barnsjukhus | Roma | 00168 | Italy |
| Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| FlevoResearch | Almere Stad | Flevoland | 1311 RL | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | Limburg | 6229 HX | Netherlands |
| Mondriaan Zorggroep Heerlen, Kinder en Jeugdp sychiatrie | Maastricht | 6229 | Netherlands |
| Hospital Son Llàtzer, Laboratorio de Neurociencias IUNICS | Palma | Balearic Islands | 07198 | Spain |
| Policlínica Guipuzkoa | Donostia / San Sebastian | Guipuzcoa | 20009 | Spain |
| Hospital Fundacion Alcorcon | Alcorcón | Madrid | 289221 | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Instituto Valenciano de Neurología Pediatrica | Valencia | 46010 | Spain |
| Barn och Ungdomsmedicin klinik Mölnlycke | Mölnlycke | 435 30 | Sweden |
| Norfolk Community Health and Care NHS Trust | Norwich | England | NR4 7PA | United Kingdom |
| Ryegate Children's Centre | Sheffield | England | S10 5DD | United Kingdom |
| Centenary House Child and Adolescent Mental Health Services | Sheffield | England | S6 3BR | United Kingdom |
| Queen Elizabeth II Hospital | Welwyn Garden City | England | AL7 4HQ | United Kingdom |
| Thurrock Community Hospital | Grays | RM16 2PX | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L12 2AP | United Kingdom |
| Lister Hospital | Stevenage | SG1 4AB | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Randomized-Withdrawal Phase |
|
|
Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study. Two subjects did not receive investigational product, therefore n = 526.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Guanfacine Hydrochloride | Administered as a once-daily oral dose between 1-7mg/day depending on age and weight |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Randomized Full Analysis Set (FAS) defined as all subjects who were randomized and took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. Subjects from Site 801 were excluded from the Randomized FAS. | Posted | Number | 95% Confidence Interval | percentage of treatment failures | 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. | Randomized FAS | Posted | Median | 95% Confidence Interval | Days | 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. | Randomized FAS | Posted | Least Squares Mean | Standard Error | units on a scale | 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) | Randomized FAS | Posted | Number | percentage of subjects | 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. | Randomized FAS | Posted | Least Squares Mean | Standard Error | units on a scale | 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. | Randomized FAS | Posted | Mean | Standard Deviation | units on a scale | 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. | Randomized Safety Population defined as all subjects who were randomized and who took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. | Posted | Number | participants | 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. | Open-label Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of any investigational product during the study. The Subjects from Site 801 were excluded from the Open-label FAS. | Posted | Mean | Standard Deviation | units on a scale | 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. | Open-label FAS | Posted | Number | percentage of participants | 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. | Open-label FAS | Posted | Number | percentage of participants | 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) | Open-label FAS | Posted | Number | percentage of participants | 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. | Open-label FAS | Posted | Mean | Standard Deviation | units on a scale | 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. | Open-label FAS | Posted | Mean | Standard Deviation | units on a scale | 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. | Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study. | Posted | Number | participants | 13 weeks |
|
|
Not provided
Open-label and Randomized Safety Populations consist of all subjects who took at least 1 dose of investigational product during their specific Phase. Two subjects in the Open-label Phase (n=526) and one subject in the Randomized-withdrawal Phase (n=315) did not receive investigational product and were excluded from their respective populations.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guanfacine Hydrochloride (Open-Label Phase) | Administered as a once-daily oral dose between 1-7mg/day depending on age and weight | 5 | 526 | 423 | 526 | ||
| EG001 | Placebo (Randomized-Withdrawal Phase) | Administered as a once-daily oral dose | 4 | 158 | 51 | 158 | ||
| EG002 | Guanfacine Hydrochloride (Randomized-Withdrawal Phase) | Administered as a once-daily oral dose between 1-7mg/day depending on age and weight | 2 | 157 | 65 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Aggression | Psychiatric disorders |
| |||
| Abdominal pain lower | Gastrointestinal disorders |
| |||
| Grand mal convulsion | Nervous system disorders |
| |||
| Conduct disorder | Psychiatric disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Family stress | Social circumstances |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Irritability | General disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Sedation | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Pyrexia | General disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Treatment failure criteria met |
|
| Other |
|
| FRANCE |
|
| GERMANY |
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| ITALY |
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| NETHERLANDS |
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| SPAIN |
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| SWEDEN |
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| UNITED KINGDOM |
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| UNITED STATES |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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