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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained. Our hypotheses are: A) GXR will be superior to placebo at reducing symptoms of ADHD as measured by standardized clinical diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment measures, GXR at week 4 of treatment will increase the amplitude of the right frontal N200 and frontal-central P300, and such changes will correlate with clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). |
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| Guanfacine Extended Release | Experimental | Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanfacine Extended Release | Drug | Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dupaul ADHD Rating Scale | 54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range. | Baseline and Follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression- Improvement | Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse | Week 4 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Pliszka, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Of Psychiatry, University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
After diagnostic assessment and confirmation that subjects meet study criteria, subjects were scheduled for a baseline EEG and they performed the Stop Signal Task while ERP data was obtained. 42 subjects completed baseline evaluation,13 did not complete baseline EEG, leaving 29 to be randomized to drug
Subjects were recruited from 4/2010 through 6/2011 primarily through flyers in child psychiatry clinics and by informing families who called the clinic intake line.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). |
| FG001 | Guanfacine Extended Release |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day. |
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Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). |
| BG001 | Guanfacine Extended Release | Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). |
| 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 | Number | 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 | Dupaul ADHD Rating Scale | 54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Follow up |
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| Secondary | Clinical Global Impression- Improvement | Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse | Posted | Mean | Standard Deviation | units on a scale | Week 4 of study |
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Adverse events assessed at each visit covering the week prior
Adverse events were spontaneously reported by patients
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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 | Placebo | Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). | 0 | 13 | 5 | 13 | ||
| EG001 | Guanfacine Extended Release | Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). | 0 | 16 | 10 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomachache | Gastrointestinal disorders | Non-systematic Assessment | Self report by child or parent |
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| Dizziness | General disorders | Non-systematic Assessment | Self report by parent or child |
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| Sedation | General disorders | Non-systematic Assessment | Self report by parent or child |
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| Fatigue | General disorders | Non-systematic Assessment | Self report by parent or child |
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The intent of the study was to examine ERP waveforms associated with impulse control. Unfortuanately, the Stop signal task and EEG proved very difficult for this young group of subjects. The ERP data could not be fully analyzed and is not reported.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven R.Pliszka MD | University of Texas Health Science Center at San Antonio | 210-567-5475 | pliszka@uthscsa.edu |
| 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 |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| >=65 years |
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| Male |
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