A 28-week single-arm trial to evaluate the efficacy, safety and tolerability of TSupport (a Traditional Chinese Medicine) for adults with Tourette Syndrome.
This study is to evaluate the efficacy, safety and tolerability of TSupport (a Traditional Chinese Medicine) for adults with Tourette Syndrome, which consists of a screening/wash-out period of up to 6 weeks, a 24-week supportive care period and a 4-week follow-up period. During the first 2-week follow-up period, subjects will continue to receive TSupport at half dose. After informed consent conducted and signed, subjects will receive TSupport orally twice daily. Morning dose and evening dose should be administrated at about the same time every day and irrelevant to meals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
TSupport is made up of 11 Chinese medicinal herbs.
Yale Child Study Center
New Haven, Connecticut, United States
The change from baseline to Week 24 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS).
The Yale Global Tic Severity Scale (YGTSS) is a semi-structured clinical interview for assessing the severity of tics in children and adults. The YGTSS enables evaluations of number, frequency, intensity, complexity, and interference of motor and phonic tics, covering the past week. Each domain is scored on a 6-point scale (range 0-5) with a separate rating for "overall impairment" regarding the subject's daily life and activities. YGTSS-TTS is the sum of the total motor tic score plus the total phonic tic score ranging from 0-50. Higher scores indicate greater severity/worse outcome. The score of TTS on week 24 will be compared to baseline.
Time frame: Baseline, Week 24
The change from baseline to Week 24 in YGTSS tic-related impairment (TRI) scores.
The score of TRI on week 24 will be compared to baseline. The YGTSS ranking of impairment (YGTSS-TRI), with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. Higher scores indicate greater severity/worse outcome.
Time frame: Baseline, Week 24
Mean change from baseline to Week 24 in TS-CGI severity and improvement.
The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. Lower scores indicate better quality of life. Mean score was calculated with TSupport group, on week 2, 4, 6, 8, 10, 12, 16, 20 and 24.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS at different check points.
Clinical response defined as a ≥ 30% reduction from baseline on TTS at week 2, 4, 6, 8, 10, 12, 16, 20 and 24. The clinical response rate is the proportion of subjects who achieve clinical response.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24