Tourette DisorderPhase 4NCT01547000
Guanfacine in Children With Tic Disorders
A Phase 4 study testing extended-release guanfacine (Intuniv) in people with Tourette Disorder and Tourette Syndrome, run by Yale University at 3 sites in United States.
Trial summary
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tourette Disorder, Tourette Syndrome
- What is being tested?
- extended-release guanfacine (Intuniv)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2012to Dec 2016
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.
- Between ages 6 yrs 0 mos and 17 years 0 months.
- Weight >/= 15 kg (33 lbs).
- Ability to swallow pills whole.
Who cannot join
- IQ < 80.
- Positive pregnancy test.
- Positive drug test.
- Low blood pressure.
- Prior history of hypersensitivity to guanfacine.
- Prior failed treatment with an adequate trial of guanfacine in last 2 years.
- Concurrent treatment with another psychoactive medication for tics, stimulant medication, or Habit Reversal therapy.
- Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; SSRIs are allowed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Yale Child Study Center
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
University of South Florida
Tampa, Florida, 33612
About this study
Official title: Guanfacine in Children With Tic Disorders: A Multi-site Study
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).
Read the detailed description
Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.
This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.
- Conditions
- Tourette Disorder, Tourette Syndrome
- Being tested
- placebo, extended-release guanfacine (Intuniv)
- Keywords
- Tourette Syndrome, Tourette Disorder, Tics, Motor tics, Vocal tics, Intuniv, Guanfacine, Medication, Drug, Placebo, Child, Children, Adolescent
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Administered up to 8 weeks.
extended-release guanfacine (Intuniv)Drug
Also called Intuniv
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inactive placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Extended-release Guanfacine | Experimental | Not described Receives: Drug: extended-release guanfacine (Intuniv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS)
The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2016
- Study completionDec 2016
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 Tourette DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of South Florida, Shire, New York University
- Responsible party
- Sponsor
- Investigators
- Lawrence D Scahill, MSN, PhD, Study director, Emory UniversityBarbara J Coffey, MD, MS, Principal investigator, Icahn School of Medicine at Mount SinaiTanya Murphy, MD, MS, Principal investigator, University of South FloridaThomas Fernandez, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547000
- Sponsor's protocol ID
- 1004006635
- Status last verified
- Aug 2021
- First submitted
- 1 Mar 2012
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guanfacine in Children With Tic Disorders: A Multi-site Study
- ClinicalTrials.gov ID
- NCT01547000
- Acronym / sponsor ID
- 1004006635
- Conditions
- Tourette Disorder, Tourette Syndrome
- Keywords
- Tourette Syndrome, Tourette Disorder, Tics, Motor tics, Vocal tics, Intuniv, Guanfacine, Medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of South Florida, Shire, New York University
- Study start
- Apr 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).
Detailed description
Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.
This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.
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 |
|---|---|---|
| Inactive placebo | Placebo comparator | Drug: placebo |
| Extended-release Guanfacine | Experimental | Drug: extended-release guanfacine (Intuniv) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.
- Between ages 6 yrs 0 mos and 17 years 0 months.
- Weight >/= 15 kg (33 lbs).
- Ability to swallow pills whole.
Key exclusion criteria (8 listed)
- IQ < 80.
- Positive pregnancy test.
- Positive drug test.
- Low blood pressure.
- Prior history of hypersensitivity 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 |
|---|---|---|
| placeboAdministered up to 8 weeks. | Drug | Inactive placebo |
| extended-release guanfacine (Intuniv)Also: Intuniv1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks. | Drug | Extended-release Guanfacine |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: 8 weeks
The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- 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.
Lawrence D Scahill, MSN, PhD study director
Emory University
Barbara J Coffey, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
Tanya Murphy, MD, MS principal investigator
University of South Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing extended-release guanfacine (Intuniv) in people with Tourette Disorder and Tourette Syndrome, run by Yale University at 3 sites 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 4 inclusion and 8 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 8 Jun 2018). 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?
Yale Global Tic Severity Scale (YGTSS) (time frame: 8 weeks). 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 13 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.