Trial Outcomes & Findings for Guanfacine in Children With Tic Disorders (NCT NCT01547000)
NCT ID: NCT01547000
Last Updated: 2021-08-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-08-13
Participant Flow
Participant milestones
| Measure |
Inactive Placebo
placebo: Administered up to 8 weeks
|
Extended-release Guanfacine
extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Guanfacine in Children With Tic Disorders
Baseline characteristics by cohort
| Measure |
Inactive Placebo
n=18 Participants
placebo: Administered up to 8 weeks
|
Extended-release Guanfacine
n=16 Participants
extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
11.5 years
STANDARD_DEVIATION 11 • n=7 Participants
|
11.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Tanner stage
Stage 1 or 2
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Tanner stage
Stage 3+
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Yale Global Tic Severity Scale (YGTSS)
Total Tic Score
|
27.7 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
26.3 units on a scale
STANDARD_DEVIATION 6.61 • n=7 Participants
|
27.0 units on a scale
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Yale Global Tic Severity Scale (YGTSS)
Total Motor score
|
17.2 units on a scale
STANDARD_DEVIATION 3.44 • n=5 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 2.61 • n=7 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Yale Global Tic Severity Scale (YGTSS)
Total Phonic score
|
10.4 units on a scale
STANDARD_DEVIATION 6.73 • n=5 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 6.13 • n=7 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Yale Global Tic Severity Scale (YGTSS)
Impairment
|
28.6 units on a scale
STANDARD_DEVIATION 8.01 • n=5 Participants
|
29.8 units on a scale
STANDARD_DEVIATION 8.18 • n=7 Participants
|
29.2 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Clinical Global Impressions (CGI)
Moderately ill
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Clinical Global Impressions (CGI)
Markedly ill
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Clinical Global Impressions (CGI)
Severely ill
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Tic Symptom Self-Report (TSSR)
|
24.6 units on a scale
STANDARD_DEVIATION 16.94 • n=5 Participants
|
26.9 units on a scale
STANDARD_DEVIATION 22.83 • n=7 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 28.5 • n=5 Participants
|
|
Premonitory Urge for Tics Scale (PUTS)
|
20.9 units on a scale
STANDARD_DEVIATION 8.18 • n=5 Participants
|
19.8 units on a scale
STANDARD_DEVIATION 5.39 • n=7 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder Rating Scale (parent)
|
17.5 units on a scale
STANDARD_DEVIATION 13.65 • n=5 Participants
|
19.7 units on a scale
STANDARD_DEVIATION 12.29 • n=7 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
Disruptive Behavior Rating Scale (DBRS)
|
5.6 units on a scale
STANDARD_DEVIATION 7.37 • n=5 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 6.59 • n=7 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
|
10.5 units on a scale
STANDARD_DEVIATION 11.43 • n=5 Participants
|
9.6 units on a scale
STANDARD_DEVIATION 10.41 • n=7 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Rage Outbursts and Anger Rating Scale (ROARS)
|
2.2 units on a scale
STANDARD_DEVIATION 2.87 • n=5 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 2.87 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe 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.
Outcome measures
| Measure |
Inactive Placebo
n=18 Participants
placebo: Administered up to 8 weeks.
|
Extended-release Guanfacine
n=16 Participants
extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
|
|---|---|---|
|
Yale Global Tic Severity Scale (YGTSS)
Impairment
|
23.44 units on a scale
Standard Deviation 11.51
|
26.44 units on a scale
Standard Deviation 9.61
|
|
Yale Global Tic Severity Scale (YGTSS)
Total tic score
|
24.72 units on a scale
Standard Deviation 10.54
|
23.56 units on a scale
Standard Deviation 6.42
|
|
Yale Global Tic Severity Scale (YGTSS)
Total Motor score
|
15.00 units on a scale
Standard Deviation 5.87
|
12.94 units on a scale
Standard Deviation 3.43
|
|
Yale Global Tic Severity Scale (YGTSS)
Total Phonic Score
|
9.72 units on a scale
Standard Deviation 6.43
|
10.63 units on a scale
Standard Deviation 5.49
|
Adverse Events
Inactive Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Extended-release Guanfacine
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inactive Placebo
n=18 participants at risk
placebo: Administered up to 8 weeks
|
Extended-release Guanfacine
n=16 participants at risk
extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Psychiatric disorders
depressed mood
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Inactive Placebo
n=18 participants at risk
placebo: Administered up to 8 weeks
|
Extended-release Guanfacine
n=16 participants at risk
extended-release guanfacine (Intuniv): 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
General disorders
Fatigue/tiredness
|
16.7%
3/18
|
87.5%
14/16
|
|
General disorders
Drowsiness
|
16.7%
3/18
|
75.0%
12/16
|
|
General disorders
Dry mouth
|
22.2%
4/18
|
62.5%
10/16
|
|
General disorders
Headache
|
11.1%
2/18
|
62.5%
10/16
|
|
Social circumstances
Irritability
|
5.6%
1/18
|
56.2%
9/16
|
|
Gastrointestinal disorders
Stomach ache
|
11.1%
2/18
|
50.0%
8/16
|
|
General disorders
Decreased appetite
|
16.7%
3/18
|
50.0%
8/16
|
|
Psychiatric disorders
Depressed mood
|
5.6%
1/18
|
43.8%
7/16
|
|
General disorders
Dizziness
|
5.6%
1/18
|
43.8%
7/16
|
|
General disorders
Emotional/tearful
|
22.2%
4/18
|
37.5%
6/16
|
|
General disorders
Daydreaming
|
11.1%
2/18
|
37.5%
6/16
|
|
General disorders
Trouble falling asleep
|
22.2%
4/18
|
31.2%
5/16
|
|
Cardiac disorders
Hypotension
|
5.6%
1/18
|
18.8%
3/16
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/18
|
18.8%
3/16
|
|
Eye disorders
Other vision problems
|
0.00%
0/18
|
18.8%
3/16
|
|
Psychiatric disorders
Anxiety
|
22.2%
4/18
|
12.5%
2/16
|
|
General disorders
Mid-sleep awakening
|
16.7%
3/18
|
12.5%
2/16
|
|
General disorders
Increased energy
|
22.2%
4/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18
|
12.5%
2/16
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18
|
12.5%
2/16
|
|
General disorders
Increased appetite
|
11.1%
2/18
|
12.5%
2/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place