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The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate + SPD503 | Experimental |
| |
| Amphetamine + SPD503 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate + SPD503 (Guanfacine hydrochloride) | Drug |
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| Amphetamine + SPD503 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total 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 |
|---|---|---|
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | 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 |
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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 |
|---|---|---|---|
| 19877974 | Result | Spencer TJ, Greenbaum M, Ginsberg LD, Murphy WR. Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):501-10. doi: 10.1089/cap.2008.0152. |
| Label | URL |
|---|---|
| FDA-approved label | View source |
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Dose titration of SPD503 (Guanfacine HCl) for 3 weeks starting at 1 mg/day and increased in 1 mg weekly increments up to 4 mg/day (or to the highest tolerated dose); then dose maintenance for 3 weeks; then downward titration of SPD503 at 1 mg weekly decrements for 3 weeks while maintaining the subject's current psychostimulant dose and frequency.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate + SPD503 | Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions. |
| FG001 | Amphetamine + SPD503 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total 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. |
| Baseline and 6 weeks |
| Number of Participants With Improvement on Parent Global Assessment (PGA) Scores | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. 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) Scores 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 for each. Increases in scores represent improved well-being in subjects as assessed by their parents. | Baseline and 6 weeks |
Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate + SPD503 | Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions. |
| BG001 | Amphetamine + SPD503 | Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total 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. | Full Analysis Set (FAS) defined as all subjects with a baseline and at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 6 weeks |
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| Secondary | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | 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. | FAS | Posted | Number | Participants | 6 weeks |
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| Secondary | Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total 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. | FAS | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 6 weeks |
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| Secondary | Number of Participants With Improvement on Parent Global Assessment (PGA) Scores | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | FAS | Posted | Number | Participants | 6 weeks |
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| Secondary | Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores 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 for each. Increases in scores represent improved well-being in subjects as assessed by their parents. | FAS | Posted | Mean | Standard Deviation | 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 | Methylphenidate + SPD503 | Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions. | 0 | 42 | 41 | 42 | ||
| EG001 | Amphetamine + SPD503 | Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions. | 0 | 33 | 29 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Appetite increased | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Sedation | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | Non-systematic Assessment |
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| Social avoidant behavior | Psychiatric disorders | Non-systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D016316 | Guanfacine |
| D000661 | Amphetamine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
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| >=65 years |
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| Male |
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| <0.0001 |
| 95 |
| Superiority or Other (legacy) |
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