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The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD503 (Guanfacine HCl) (1 mg) | Experimental |
| |
| SPD503 (2 mg) | Experimental |
| |
| SPD503 (3 mg) | Experimental |
| |
| SPD503 (4 mg) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD503 (1 mg) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19106767 | Result | Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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Although 324 subjects were randomized, 2 never received drug and therefore were not included in the Baseline Characteristics. Subjects received either 1, 2, 3, or 4 mg of SPD503 (Guanfacine hydrochloride) or placebo once daily.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD503 (1 mg) | Guanfacine HCl once daily |
| FG001 | SPD503 (2 mg) | Guanfacine HCl once daily |
| FG002 | SPD503 (3 mg) | Guanfacine HCl once daily |
| FG003 | SPD503 (4 mg) | Guanfacine HCl once daily |
| FG004 | Placebo | once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD503 (1 mg) | Guanfacine HCl once daily |
| BG001 | SPD503 (2 mg) | Guanfacine HCl once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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. | Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPD503 (1 mg) | Guanfacine HCl once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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| SPD503 (2 mg) |
| Drug |
|
| SPD503 (3 mg) | Drug |
|
| SPD503 (4 mg) | Drug |
|
| Placebo | Drug |
|
| Baseline and 6 weeks |
| Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | 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. | 6 weeks |
| Number of Participants With Improvement in Parent Global Assessment (PGA) | Parent Global Assessment (PGA) 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. | 6 weeks |
| Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks | The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. | Baseline and 6 weeks |
| FDA-approved label | View source |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Lack of Efficacy |
|
| No study meds |
|
| Physician Decision |
|
| Lack of compliance |
|
| Abnormal ECG |
|
| Sponsor's decision |
|
| BG002 |
| SPD503 (3 mg) |
Guanfacine HCl once daily |
| BG003 | SPD503 (4 mg) | Guanfacine HCl once daily |
| BG004 | Placebo | once daily |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Guanfacine HCl once daily |
| OG002 | SPD503 (3 mg) | Guanfacine HCl once daily |
| OG003 | SPD503 (4 mg) | Guanfacine HCl once daily |
| OG004 | Placebo | once daily |
|
|
|
| Secondary | Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | ITT | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and 6 weeks |
|
|
|
|
| Secondary | Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | 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. | ITT | Posted | Number | Participants | 6 weeks |
|
|
|
|
| Secondary | Number of Participants With Improvement in Parent Global Assessment (PGA) | Parent Global Assessment (PGA) 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. | ITT | Posted | Number | Participants | 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks | The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. | ITT | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 6 weeks |
|
|
|
|
| 0 |
| 61 |
| 49 |
| 61 |
| EG001 | SPD503 (2 mg) | Guanfacine HCl once daily | 0 | 65 | 40 | 65 |
| EG002 | SPD503 (3 mg) | Guanfacine HCl once daily | 1 | 65 | 45 | 65 |
| EG003 | SPD503 (4 mg) | Guanfacine HCl once daily | 0 | 65 | 55 | 65 |
| EG004 | Placebo | once daily | 1 | 66 | 45 | 66 |
| Convulsion | Nervous system disorders | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Lethargy | General disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
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.
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| 95 |
| Superiority or Other (legacy) |
| ANCOVA | 0.0056 | 95 | Superiority or Other (legacy) |
| ANCOVA | 0.0237 | 95 | Superiority or Other (legacy) |
| 95 |
| Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.0055 | 95 | Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.0041 | 95 | Superiority or Other (legacy) |
| 95 |
| Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.0017 | 95 | Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.0063 | 95 | Superiority or Other (legacy) |
| Psychosocial |
|
| 0.5859 |
| 95 |
| Superiority or Other (legacy) |
| Psychosocial category | ANCOVA | 0.2136 | 95 | Superiority or Other (legacy) |
| Psychosocial category | ANCOVA | 0.1483 | 95 | Superiority or Other (legacy) |