A Phase 4 interventional study of Guanfacine Extended Release and Placebo in Attention Deficit Disorder With Hyperactivity, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2012-09-03.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 42 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
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Exclusion Criteria:
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).
Drug: Placebo
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).
Drug: Guanfacine Extended Release
Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.
Also known as: Intuniv
Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
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.
Time frame: Baseline and Follow up
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
Time frame: Week 4 of study
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.
| Milestone | Placebo | Guanfacine Extended Release |
|---|---|---|
| Started | 13 | 16 |
| Completed | 9 | 9 |
| Not completed | 4 | 7 |
| Withdrew: Withdrawal by subject | 4 | 7 |
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.
| units on a scale | Placebo | Guanfacine |
|---|---|---|
| Dupaul ADHD Rating Scale | 31.4 ± 16.5 | 13.6 ± 9.7 |
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
| units on a scale | Placebo | Guanfacine |
|---|---|---|
| Clinical Global Impression- Improvement | 3.0 ± 1.1 | 2.0 ± 0.5 |
Collected over Adverse events assessed at each visit covering the week prior. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/13 (0%) | 5/13 (38.5%) |
| Guanfacine Extended Release | — | 0/16 (0%) | 10/16 (62.5%) |
| Event | Placebo | Guanfacine Extended Release |
|---|---|---|
| SedationGeneral disorders | 3/13 | 5/16 |
| FatigueGeneral disorders | 0/13 | 3/16 |
| StomachacheGastrointestinal disorders | 1/13 | 1/16 |
| DizzinessGeneral disorders | 1/13 | 1/16 |
| Age, Categorical(Participants) | Placebo | Guanfacine Extended Release | Total |
|---|---|---|---|
| <=18 years | 13 | 16 | 29 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Placebo | Guanfacine Extended Release | Total |
|---|---|---|---|
| Mean | 8.78 ± 1.8 | 7.8 ± 1.2 | 8.29 ± 1.5 |
| Sex: Female, Male(Participants) | Placebo | Guanfacine Extended Release | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 6 | 10 | 16 |
| Region of Enrollment(participants) | Placebo | Guanfacine Extended Release | Total |
|---|---|---|---|
| United States | 13 | 16 | 29 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio