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Guanfacine in Children With Tic Disorders

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ClinicalTrials.gov Identifier: NCT01547000
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
University of South Florida
Shire
New York University
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tourette Disorder
Tourette Syndrome
Interventions Drug: placebo
Drug: extended-release guanfacine (Intuniv)
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inactive Placebo Extended-release Guanfacine
Hide Arm/Group Description placebo: Administered up to 8 weeks extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Period Title: Overall Study
Started 18 16
Completed 18 16
Not Completed 0 0
Arm/Group Title Inactive Placebo Extended-release Guanfacine Total
Hide Arm/Group Description placebo: Administered up to 8 weeks extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
<=18 years
18
 100.0%
16
 100.0%
34
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
10.8  (3.2) 11.5  (11) 11.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
6
  33.3%
5
  31.3%
11
  32.4%
Male
12
  66.7%
11
  68.8%
23
  67.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Hispanic or Latino
4
  22.2%
3
  18.8%
7
  20.6%
Not Hispanic or Latino
14
  77.8%
13
  81.3%
27
  79.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.6%
0
   0.0%
1
   2.9%
White
17
  94.4%
16
 100.0%
33
  97.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Tanner stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Stage 1 or 2
11
  61.1%
10
  62.5%
21
  61.8%
Stage 3+
7
  38.9%
6
  37.5%
13
  38.2%
[1]
Measure Description: The Tanner scale categorizes physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitals, testicular volume and development of pubic hair in children, adolescents, and adults. Stages are based on physical examination. Stages are not indicative of better or worse outcome. There is insufficient space given in this form to list all of the measurements here. In brief, Stage 1: no pubic hair; Stage 2: initial growth of pubic hair, breasts, nipples, scrotum, testes; Stage 3: additional growth of all mentioned in Stage 2.
Yale Global Tic Severity Scale (YGTSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
Total Tic Score 27.7  (8.7) 26.3  (6.61) 27.0  (10.9)
Total Motor score 17.2  (3.44) 15.2  (2.61) 16.3  (4.3)
Total Phonic score 10.4  (6.73) 11.1  (6.13) 10.7  (9.1)
Impairment 28.6  (8.01) 29.8  (8.18) 29.2  (11.4)
[1]
Measure Description: 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.
Clinical Global Impressions (CGI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Moderately ill
9
  50.0%
12
  75.0%
21
  61.8%
Markedly ill
6
  33.3%
4
  25.0%
10
  29.4%
Severely ill
3
  16.7%
0
   0.0%
3
   8.8%
Tic Symptom Self-Report (TSSR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
24.6  (16.94) 26.9  (22.83) 25.7  (28.5)
[1]
Measure Description: The TSSR (Cohen and Leckman 1984) was completed by a parent or caretaker. It includes 20 motor and 20 phonic tics, each rated 0 to 3. The motor and phonic scores are summed to create a total score. The total score for Tic Symptom Self-Report ranged from 0-120. Higher scores means greater severity/worse outcome. It has been shown to be sensitive to treatment effects (Scahill et al. 2003).
Premonitory Urge for Tics Scale (PUTS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
20.9  (8.18) 19.8  (5.39) 20.4  (9.8)
[1]
Measure Description: The PUTS (Woods et al. 2005) is a 10-item self-report measure of premonitory urges in individuals with tics. Individual item scores (1-4) are summed, yielding a total score (10-40) reflecting the presence and frequency of pre-tic (i.e., premonitory) urges along with relief that may be experienced after tics have been completed. Higher scores means higher frequency of premonitory urges.
Attention-Deficit/Hyperactivity Disorder Rating Scale (parent)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
17.5  (13.65) 19.7  (12.29) 18.5  (18.4)
[1]
Measure Description: The ADHD Rating Scale (Reid et al. 1998) is an 18-item, DSM-IV referenced measure rated by a parent or caretaker in this study. The sum of nine inattention items and nine hyperactivity/impulsiveness items (each rated on a 0-3 scale) are included in the total score. The total score for the Attention-Deficit/Hyperactivity Disorder Rating Scale (parent) ranged from 0 to 54. A higher score means greater severity of ADHD symptoms.
Disruptive Behavior Rating Scale (DBRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
5.6  (7.37) 8.8  (6.59) 7.1  (9.9)
[1]
Measure Description: The DBRS (Barkley and Murphy 2006) is an 8-item measure of oppositional defiant disorder rated by the parent or caretaker, with each item rated on a 0 to 3 scale. The total score is the sum of all 8 item scores. The total score for the Disruptive Behavior Rating Scale (DBRS) ranged from 0 to 24. Higher scores means greater severity of disruptive behaviors. Scores of 12 and higher are considered clinically significant.
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
10.5  (11.43) 9.6  (10.41) 10.1  (15.5)
[1]
Measure Description: The CY-BOCS (Scahill et al. 1997) is a 10-item, semistructured interview administered by the independent evaluator and is designed to rate the severity of obsessive-compulsive disorder. Scores range from 0 to 40 with higher scores indicating greater severity.
Rage Outbursts and Anger Rating Scale (ROARS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
2.2  (2.87) 3.1  (2.87) 2.6  (4.1)
[1]
Measure Description: The ROARS (Budman et al. 2008) is a 3-item, clinician-rated scale designed to quantify the severity of explosive outbursts in the past week, administered by an independent evaluator. The items are rated from 0 to 3 on frequency, intensity, and duration and then added together for a total score. The total score for the Rage Outbursts and Anger Rating Scale (ROARS) ranged from 0 to 9. Higher scores indicates greater severity.
1.Primary Outcome
Title Yale Global Tic Severity Scale (YGTSS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive Placebo Extended-release Guanfacine
Hide Arm/Group Description:
placebo: Administered up to 8 weeks.
extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total tic score 24.72  (10.54) 23.56  (6.42)
Total Motor score 15.00  (5.87) 12.94  (3.43)
Total Phonic Score 9.72  (6.43) 10.63  (5.49)
Impairment 23.44  (11.51) 26.44  (9.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inactive Placebo Extended-release Guanfacine
Hide Arm/Group Description placebo: Administered up to 8 weeks extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
All-Cause Mortality
Inactive Placebo Extended-release Guanfacine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Inactive Placebo Extended-release Guanfacine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      1/16 (6.25%)    
Psychiatric disorders     
depressed mood   0/18 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inactive Placebo Extended-release Guanfacine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/18 (22.22%)      14/16 (87.50%)    
Cardiac disorders     
Hypotension   1/18 (5.56%)  3/16 (18.75%) 
Eye disorders     
Other vision problems   0/18 (0.00%)  3/16 (18.75%) 
Gastrointestinal disorders     
Stomach ache   2/18 (11.11%)  8/16 (50.00%) 
Constipation   2/18 (11.11%)  2/16 (12.50%) 
Nausea   2/18 (11.11%)  2/16 (12.50%) 
General disorders     
Fatigue/tiredness   3/18 (16.67%)  14/16 (87.50%) 
Drowsiness   3/18 (16.67%)  12/16 (75.00%) 
Dry mouth   4/18 (22.22%)  10/16 (62.50%) 
Headache   2/18 (11.11%)  10/16 (62.50%) 
Decreased appetite   3/18 (16.67%)  8/16 (50.00%) 
Dizziness   1/18 (5.56%)  7/16 (43.75%) 
Emotional/tearful   4/18 (22.22%)  6/16 (37.50%) 
Daydreaming   2/18 (11.11%)  6/16 (37.50%) 
Trouble falling asleep   4/18 (22.22%)  5/16 (31.25%) 
Mid-sleep awakening   3/18 (16.67%)  2/16 (12.50%) 
Increased energy   4/18 (22.22%)  0/16 (0.00%) 
Increased appetite   2/18 (11.11%)  2/16 (12.50%) 
Psychiatric disorders     
Depressed mood   1/18 (5.56%)  7/16 (43.75%) 
Anxiety   4/18 (22.22%)  2/16 (12.50%) 
Skin and subcutaneous tissue disorders     
Skin rash   0/18 (0.00%)  3/16 (18.75%) 
Social circumstances     
Irritability   1/18 (5.56%)  9/16 (56.25%) 
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tanya K. Murphy, MD, MS
Organization: University of South Florida
Phone: 813-974-2201
EMail: tmurphy@health.usf.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01547000    
Other Study ID Numbers: 1004006635
First Submitted: March 1, 2012
First Posted: March 7, 2012
Results First Submitted: January 15, 2018
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018