Evaluate the Efficacy, Safety and Tolerability of TSUPPORT for Adults With Tourette Syndrome

Pilot Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of TSUPPORT (a Traditional Chinese Medicine) for Adults With Tourette Syndrome

A 28-week single-arm trial to evaluate the efficacy, safety and tolerability of TSupport (a Traditional Chinese Medicine) for adults with Tourette Syndrome.

Study Overview

• Status: Not yet recruiting
• Conditions: Tourette Syndrome
• Intervention / Treatment: Dietary supplement: TSupport (a Traditional Chinese Medicine)

Detailed Description

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
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael H Bloch, MD, PhD; Phone Number: 203-974-7551; Email: michael.bloch@yale.edu
• Study Contact Backup: Name: James F Leckman, MD, PhD; Phone Number: 203-785-7971; Email: james.leckman@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Child Study Center
      • Contact: Michael H Bloch, MD, PhD; Phone Number: 203-974-7551; Email: michael.bloch@yale.edu
      • Contact: James F Leckman, MD, PhD; Phone Number: 203-785-7971; Email: james.leckman@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female adult (aged 18-65) with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
2. Total Tic Score (TTS) ≥ 20 on the Yale Global Tic Severity Scale (YGTSS) at screening and baseline.
3. In investigator's opinion the presenting tic symptoms cause at least a moderate degree of distress or impairment.
4. On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial including medications thought to effect tic symptoms.
5. Females of childbearing potential had a negative pregnancy test, must agree to practiced acceptable double-barrier methods of contraception (or abstinence), and were not pregnant or lactating.
6. Willing to participate voluntarily and sign a written informed consent form.
7. In the opinion of the investigator, the subject is considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion Criteria:

1. Medical history consistent with another neurologic condition that may have had accompanying abnormal movements (e.g., Huntington's disease, Parkinson's disease, Sydenham's chorea, Wilson's disease, Mental retardation, Traumatic brain injury, Stroke, Restless legs syndrome);
2. History of schizophrenia, bipolar disorder, or other psychotic disorder; intellectual disability or Autism Spectrum Disorder (Level 2 or 3 functioning - requiring substantial social supports or more);
3. Recent change (less than 4 weeks) in medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen, VMAT2 inhibitors, ecopipam or compounds containing delta-9 tetrahydrocannabinol (delta-9-THC) or cannabidiol). Medication change is defined to include dose changes or medication discontinuation.
4. Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
5. Sexually active males or females who would not commit to utilizing 2 of the approved birth control methods or who would not remain abstinent during the trial and for 90 days (males) or 30 days (females) following the last dose of IP
6. Significant psychoactive substance use disorder within the past 3 months; or the urine drug screen was positive for cocaine, opiates, amphetamines, benzodiazepines or marijuana. Subjects prescribed stable medications that cause positive drug tests e.g. benzodiazepines, dronabinol or psychostimulants will be included as long as they do not test positive for substances unexplained by their prescription medication.

7. Significant lab abnormality:

   1. Platelets ≤ 75,000/mm3
   2. Hemoglobin ≤ 9 g/dl
   3. Neutrophils, absolute ≤ 1000/mm3
   4. Aspartate transaminase (AST) > 3×ULN (upper limit of normal)
   5. Alanine aminotransferase (ALT) > 3×ULN
   6. Creatinine ≥ 2 mg/dl
8. History or presence of any clinically important medical condition that, in the judgment of the investigator, is likely to deteriorate, could be detrimental to the subject, or could affect the subject's ability to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TSupport group; Subjects will receive TSupport 4 sachets (5 grams/sachet) orally twice daily. Morning dose and evening dose should be administrated at about the same time every day and irrelevant to meals. Supportive care duration: 24 weeks.	Dietary supplement: TSupport (a Traditional Chinese Medicine); TSupport is made up of 11 Chinese medicinal herbs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Tasly Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Michael H Bloch, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (ACTUAL): January 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Tourette Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: TSupport-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No