drugset / Trial / NCT01069523
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
Phase 4
Completed
42 enrolled
The University of Texas Health Science Center at San Antonio
Shire · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-08
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guanfacine | Small molecule | 1 mg | — |
| Subject | Guanfacine | Small molecule | 4 mg | — |