Trial Outcomes & Findings for Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder (NCT NCT01585207)
NCT ID: NCT01585207
Last Updated: 2018-01-19
Results Overview
The Global Severity score is the sum of the Total Tic score and the TD Impairment score. It is rated by the Investigator on the Yale Global Tic Severity Score ( Y-GTSS, a widely accepted measure of drug efficacy in TD. Scale from 0- 100. Higher score indicates more impairment.
COMPLETED
PHASE1/PHASE2
4 participants
weekly from baseline to end of study (10weeks)
2018-01-19
Participant Flow
Participant milestones
| Measure |
Vigabatrin
3 tablets, bid for 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder
Baseline characteristics by cohort
| Measure |
Vigabatrin
n=4 Participants
3 tablets, bid for 8 weeks
|
|---|---|
|
Age, Continuous
|
34.75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
YGTSS (total tic)
|
39 total tics
STANDARD_DEVIATION 3.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: weekly from baseline to end of study (10weeks)The Global Severity score is the sum of the Total Tic score and the TD Impairment score. It is rated by the Investigator on the Yale Global Tic Severity Score ( Y-GTSS, a widely accepted measure of drug efficacy in TD. Scale from 0- 100. Higher score indicates more impairment.
Outcome measures
| Measure |
Vigabatrin
n=4 Participants
3 tablets, bid for 8 weeks
|
|---|---|
|
Global Severity Score on the Y-GTSS
Week 1
|
61 units on a scale
Interval 36.0 to 77.0
|
|
Global Severity Score on the Y-GTSS
Baseline
|
80.25 units on a scale
Interval 76.0 to 90.0
|
|
Global Severity Score on the Y-GTSS
Week 0
|
78.75 units on a scale
Interval 75.0 to 83.0
|
|
Global Severity Score on the Y-GTSS
Week 2
|
69.75 units on a scale
Interval 63.0 to 78.0
|
|
Global Severity Score on the Y-GTSS
Week 3
|
61 units on a scale
Interval 57.0 to 68.0
|
|
Global Severity Score on the Y-GTSS
Week 4
|
59 units on a scale
Interval 49.0 to 65.0
|
|
Global Severity Score on the Y-GTSS
Week 6
|
58.75 units on a scale
Interval 44.0 to 68.0
|
|
Global Severity Score on the Y-GTSS
Week 8
|
60.88 units on a scale
Interval 44.0 to 69.5
|
|
Global Severity Score on the Y-GTSS
Week 10
|
70.33 units on a scale
Interval 53.0 to 86.0
|
Adverse Events
Vigabatrin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vigabatrin
n=4 participants at risk
3 tablets, bid for 8 weeks
|
|---|---|
|
General disorders
Fatigue
|
75.0%
3/4
|
|
General disorders
Appetite Increase
|
25.0%
1/4
|
|
General disorders
Sleep Difficulties
|
25.0%
1/4
|
|
Nervous system disorders
Increase in OCD symptoms
|
25.0%
1/4
|
|
General disorders
Dry mouth
|
25.0%
1/4
|
|
Nervous system disorders
Mood swings
|
25.0%
1/4
|
|
Nervous system disorders
Memory impairment
|
25.0%
1/4
|
|
General disorders
Daytime tiredness
|
25.0%
1/4
|
|
General disorders
Vivid dreams
|
25.0%
1/4
|
|
General disorders
Possible weight gain
|
25.0%
1/4
|
|
Eye disorders
Blurry Vision
|
25.0%
1/4
|
Additional Information
Dr. Barbara J. Coffey
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place