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NCT01069523 · ClinicalTrials.gov registry record · Phase 4
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT01069523: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01069523 is a Phase 4 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01069523, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Guanfacine Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT01069523 record still lists
NCT01069523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01069523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01069523 about?
NCT01069523 is a clinical study titled "Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)". 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 ...
What is the current status of trial NCT01069523?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2010-03. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01069523?
The interventions under investigation include: Placebo (DRUG), Guanfacine Extended Release (DRUG).
Who is sponsoring clinical trial NCT01069523?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01069523's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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