Attention Deficit Disorder With HyperactivityPhase 4NCT01069523
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4 study testing Guanfacine Extended Release in people with Attention Deficit Disorder With Hyperactivity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Guanfacine Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years
- Meet criteria for Attention Deficit Hyperactivity Disorder
Who cannot join
- Do not meet criteria for Major Depression, Bipolar, Autism
- Talking any psychotropic medication for a condition other than ADHD
- History of epilepsy, severe head injury or loss of consciousness
- History of Intolerance to guanfacine
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. Of Psychiatry, University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: Electrophysiological Effects of Guanfacine Extended-Release (GXR) on Inhibitory Control in Children With 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 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.
Read the detailed description
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.
- Being tested
- Guanfacine Extended Release, Placebo
- Keywords
- Attention Deficit Disorder with Hyperactivity, Guanfacine, Event Related Potentials
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanfacine Extended ReleaseDrug
Also called Intuniv
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Placebo |
| 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). Receives: Drug: Guanfacine Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Follow up
Secondary outcomes (1)
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
Measured: Week 4 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Steven R Pliszka, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069523
- Sponsor's protocol ID
- HSC2009-499H
- Status last verified
- Aug 2012
- First submitted
- 15 Feb 2010
- Last updated
- 3 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Effects of Guanfacine Extended-Release (GXR) on Inhibitory Control in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01069523
- Acronym / sponsor ID
- HSC2009-499H
- Keywords
- Attention Deficit Disorder with Hyperactivity, Guanfacine, Event Related Potentials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 3 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients 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). |
| Guanfacine Extended Release | Experimental | Drug: Guanfacine Extended ReleasePatients 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). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-12 years
- Meet criteria for Attention Deficit Hyperactivity Disorder
Key exclusion criteria (4 listed)
- Do not meet criteria for Major Depression, Bipolar, Autism
- Talking any psychotropic medication for a condition other than ADHD
- History of epilepsy, severe head injury or loss of consciousness
- History of Intolerance to guanfacine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guanfacine Extended ReleaseAlso: IntunivGuanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet. | Drug | Guanfacine Extended Release |
| PlaceboTable that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day. | Drug | Placebo |
Primary outcome
Dupaul ADHD Rating Scale
Time frame: Baseline and Follow up
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.
1 secondary outcome
Clinical Global Impression- Improvement
Time frame: Week 4 of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Pliszka, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine Extended Release in people with Attention Deficit Disorder With Hyperactivity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dupaul ADHD Rating Scale (time frame: Baseline and Follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.