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CompletedNCT01547000Updated Aug 13, 2021Results posted

Guanfacine in Children With Tic Disorders

A Phase 4 interventional study of placebo and extended-release guanfacine (Intuniv) in Tourette Disorder and Tourette Syndrome, sponsored by Yale University. Completed at 3 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-08-13.

Sponsored by Yale University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tourette Disorder
  • Tourette Syndrome

Keywords

  • Tourette Syndrome
  • Tourette Disorder
  • Tics
  • Motor tics
  • Vocal tics
  • Intuniv
  • Guanfacine
  • Medication
  • Drug
  • Placebo
  • Child
  • Children
  • Adolescent
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's enrollment of 34 is close to the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Browse Yale University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • IQ \< 80.
  • Positive pregnancy test.
  • Positive drug test.
  • Low blood pressure.
  • Prior history of 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Placebo comparator
    Inactive placebo

    Drug: placebo

  • Experimental
    Extended-release Guanfacine

    Drug: extended-release guanfacine (Intuniv)

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

07

Results

Posted Jun 8, 2018
Limitations and caveats
We are limited by the small size of this subgroup to determine whether children with comorbid CTD and ADHD might have a significant response to extended-release guanfacine, both with regard to tics and ADHD symptoms.

Participant flow

Participant flow — Overall Study
MilestoneInactive PlaceboExtended-release Guanfacine
Started1816
Completed1816
Not completed00

Outcome measures

PrimaryYale 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.

Time frame:
8 weeks
Reported as:
Mean · units on a scale
Yale Global Tic Severity Scale (YGTSS)
units on a scaleInactive PlaceboExtended-release Guanfacine
Total tic score24.72 ± 10.5423.56 ± 6.42
Total Motor score15.00 ± 5.8712.94 ± 3.43
Total Phonic Score9.72 ± 6.4310.63 ± 5.49
Impairment23.44 ± 11.5126.44 ± 9.61

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Inactive Placebo0/18 (0%)0/18 (0%)4/18 (22.2%)
Extended-release Guanfacine0/16 (0%)1/16 (6.3%)14/16 (87.5%)
Most frequent serious events
Most frequent serious events
EventInactive PlaceboExtended-release Guanfacine
depressed moodPsychiatric disorders0/181/16
Most frequent other events
Showing 10 of 21
Most frequent other events
EventInactive PlaceboExtended-release Guanfacine
Fatigue/tirednessGeneral disorders3/1814/16
DrowsinessGeneral disorders3/1812/16
Dry mouthGeneral disorders4/1810/16
HeadacheGeneral disorders2/1810/16
IrritabilitySocial circumstances1/189/16
Stomach acheGastrointestinal disorders2/188/16
Decreased appetiteGeneral disorders3/188/16
Depressed moodPsychiatric disorders1/187/16
DizzinessGeneral disorders1/187/16
Emotional/tearfulGeneral disorders4/186/16

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Inactive PlaceboExtended-release GuanfacineTotal
<=18 years181634
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Inactive PlaceboExtended-release GuanfacineTotal
Mean10.8 ± 3.211.5 ± 1111.1 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Inactive PlaceboExtended-release GuanfacineTotal
Female6511
Male121123
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Inactive PlaceboExtended-release GuanfacineTotal
Hispanic or Latino437
Not Hispanic or Latino141327
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Inactive PlaceboExtended-release GuanfacineTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101
White171633
More than one race000
Unknown or Not Reported000
Tanner stage
Tanner stage(Participants)Inactive PlaceboExtended-release GuanfacineTotal
Stage 1 or 2111021
Stage 3+7613
Yale Global Tic Severity Scale (YGTSS)
Yale Global Tic Severity Scale (YGTSS)(units on a scale)Inactive PlaceboExtended-release GuanfacineTotal
Total Tic Score27.7 ± 8.726.3 ± 6.6127.0 ± 10.9
Total Motor score17.2 ± 3.4415.2 ± 2.6116.3 ± 4.3
Total Phonic score10.4 ± 6.7311.1 ± 6.1310.7 ± 9.1
Impairment28.6 ± 8.0129.8 ± 8.1829.2 ± 11.4
Clinical Global Impressions (CGI)
Clinical Global Impressions (CGI)(Participants)Inactive PlaceboExtended-release GuanfacineTotal
Moderately ill91221
Markedly ill6410
Severely ill303

6 further baseline measures are reported on the registry.

08

Study locations

3 sites
  • Yale Child Study Center
    New Haven, Connecticut 06510, United States
  • University of South Florida
    Tampa, Florida 33612, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01547000
Lead sponsor
Yale University
Collaborators
Icahn School of Medicine at Mount Sinai, University of South Florida, Shire, New York University
Responsible party
Sponsor
First posted
Mar 7, 2012
Start date
Apr 2012
Primary completion
Dec 2016
Completion
Dec 2016
Results posted
Jun 8, 2018
Last update
Aug 13, 2021

Study contacts

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
Thomas Fernandez, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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