CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Guanfacine Extended Release +1 moredrug
Likely dose
Guanfacine Extended Release 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01069523
NCT01069523Phase 4Completed

Electrophysiological Effects of Guanfacine Extended-Release (GXR) on Inhibitory Control in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

The University of Texas Health Science Center at San Antonio·interventional·Posted Feb 17, 2010·Updated Sep 3, 2012

In Brief

A Phase 4 clinical trial evaluating Guanfacine Extended Release and Placebo for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.4 years ago

Interventions

Guanfacine Extended Releasedrug

Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.

Placebodrug

Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.