ClinicalTrials.gg
Status unknownNCT05183594Updated Jan 11, 2022

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

An interventional study of TSupport (a Traditional Chinese Medicine) in Tourette Syndrome, sponsored by Tasly Pharmaceuticals, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Tasly Pharmaceuticals, Inc. (part of China Resources Pharmaceutical Group Limited) · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Tourette Syndrome

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Keywords

  • Tourette Syndrome
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's planned enrollment of 10 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Tasly Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

First submitted before Tasly Pharmaceuticals, Inc. became part of China Resources Pharmaceutical Group Limited.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female adult (aged 18-65) with Tourette Syndrome according to , 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 had a negative pregnancy test, must agree to practiced acceptable double-barrier methods of (or abstinence), and were not pregnant or lactating.
  6. Willing to participate voluntarily and sign a written 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

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 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. ≤ 75,000/mm3
    2. ≤ 9 g/dl
    3. Neutrophils, absolute ≤ 1000/mm3
    4. (AST) > 3× (upper limit of normal)
    5. Alanine aminotransferase (ALT) > 3×ULN
    6. Creatinine ≥ 2 mg/dl
  8. History or presence of any 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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)

Interventions

  • Dietary supplementTSupport (a Traditional Chinese Medicine)

    TSupport is made up of 11 Chinese medicinal herbs.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24

07

Study locations

1 site
  • Yale Child Study Center
    New Haven, Connecticut 06520, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05183594
Responsible party
Sponsor
First posted
Jan 10, 2022
Start date
Mar 2022 (estimated)
Primary completion
Mar 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jan 11, 2022

Study contacts

Michael H Bloch, MD, PhD
Contact
michael.bloch@yale.edu
203-974-7551
James F Leckman, MD, PhD
Contact
James.leckman@yale.edu
203-785-7971
Michael H Bloch, MD, PhD
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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