An interventional study of T92 and Placebo in Tourette Syndrome in Children and Tourette Syndrome in Adolescence, sponsored by Tasly Pharmaceuticals, Inc.. Status unknown at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by Tasly Pharmaceuticals, Inc. · Not applicable, Interventional, and Supportive care
A 12-week clinical study to evaluate the safety and efficacy of T92 in pediatric patients with Tourette Syndrome.
This is a multi-center, randomized, double-blind, placebo-controlled, outpatient clinical study designed to evaluate the efficacy and safety of T92 in Tourette Syndrome pediatric patients.
This trial consists of a screening/wash-out period of up to 6 weeks, an 8-week supportive care period and a 4-week follow-up period for all subjects who completed the study. For the first two weeks, the patients will continue to take T92 at half dose and the T92 administration will be stopped from week 3 of the follow-up period.
Subjects will be randomly assigned to receive T92 or matching placebo based on individual body weight. The calculated amount of investigational product (T92 or placebo) will be administrated orally twice daily. Morning dose and evening dose should be administrated at about the same time every day and irrelevant to meals.
Exclusion Criteria:
Subjects who have had treatment with:
Significant lab abnormality:
The dose of T92 was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks
Dietary Supplement: T92
The dose of placebo was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks
Dietary Supplement: Placebo
T92 granules (5g/sachet) will be taken BID for 8 weeks, the dosage will be calculated by individual's body weight.
The placebo matched to T92 granules will be taken BID for 8 weeks.
The mean change from baseline to week 8 in total tic score (TTS) of Yale Global Tic Severity Scale (YGTSS).
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. Changes in TTS after 8 weeks of supportive care duration will be compared between the T92 and placebo groups.
Time frame: Baseline, Week 8
The change from baseline to Week 8 in total Yale Global Tic Severity Scale (YGTSS) scale YGTSS tic-related impairment (TRI) score at week 8
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 8
Mean change from baseline to TS-CGI severity and improvement at week 8
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 T92 and placebo group, on week 2, 4, 6, and 8.
Time frame: Baseline, Week 2, 4, 6 and 8
Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS score at different check points.
Clinical response defined as a ≥ 30% reduction from baseline on TTS at week 2, 4, 6 and 8. The clinical response rate is the proportion of subjects who achieve clinical response.
Time frame: Baseline, Week 2, 4, 6 and 8
Evaluation of T92 in reducing severity of the sensations before the emergence of tics by comparing the change in PUTS scores at week 8 from baseline.
The PUTS is a nine-item self-reported scale that measures the sensations before the emergence of tics, and each item is scored from 1 to 4. The total score (range: 9-36) is obtained by summing all of the nine items. Higher scores indicate greater severity/worse symptoms.
Time frame: Baseline, Week 4 and 8
Evaluation of T92 in reducing severity of obsessions and compulsion occurring by comparing the change in CY-BOCS scores at week 8 from baseline.
The CY-BOCS is assessing the severity of obsessions and compulsion occurring over the past week. OCD severity score (range 0-40) including all 10 items rated on a 5-point Likert scale (range 0-4). Higher scores indicate greater severity/worse symptoms.
Time frame: Baseline, Week 4 and 8
Evaluation of T92 in reducing severity of ADHD symptoms.
The ADHD-RS-IV is an 18-item scale based on the DSM-IV-TR criteria for ADHD that provides a rating of the severity of symptoms. The first 9 items assess inattentive symptoms and the last 9 items assess hyperactive-impulsive symptoms. Scoring is based on a 4-point Likert-type severity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Higher scores indicate greater severity/worse symptoms.
Time frame: Baseline, Week 4 and 8
Plan to share: No
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Tasly Pharmaceuticals, Inc.