Tourette SyndromeNCT05183594
Evaluate the Efficacy, Safety and Tolerability of TSUPPORT for Adults With Tourette Syndrome
A study testing TSupport (a Traditional Chinese Medicine) in people with Tourette Syndrome, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- TSupport (a Traditional Chinese Medicine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult (aged 18-65) with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- Total Tic Score (TTS) ≥ 20 on the Yale Global Tic Severity Scale (YGTSS) at screening and baseline.
- In investigator's opinion the presenting tic symptoms cause at least a moderate degree of distress or impairment.
- On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial including medications thought to effect tic symptoms.
- 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.
- Willing to participate voluntarily and sign a written informed consent form.
- 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.
Who cannot join
- 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);
- 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);
- 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.
- 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.
- 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
- 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.
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- Significant lab abnormality:
- Platelets ≤ 75,000/mm3
- Hemoglobin ≤ 9 g/dl
- Neutrophils, absolute ≤ 1000/mm3
- Aspartate transaminase (AST) > 3×ULN (upper limit of normal)
- Alanine aminotransferase (ALT) > 3×ULN
- Creatinine ≥ 2 mg/dl
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
Michael H Bloch, MD, PhD, 203-974-7551, michael.bloch@yale.edu
James F Leckman, MD, PhD, 203-785-7971, James.leckman@yale.edu
About this study
Official title: 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.
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.
- Conditions
- Tourette Syndrome
- Being tested
- TSupport (a Traditional Chinese Medicine)
- Keywords
- Tourette Syndrome
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSupport (a Traditional Chinese Medicine)Dietary supplement
TSupport is made up of 11 Chinese medicinal herbs.
| Study group | Role | What they receive |
|---|---|---|
| TSupport group | Experimental | 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. Receives: Dietary Supplement: TSupport (a Traditional Chinese Medicine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Bloch, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183594
- Sponsor's protocol ID
- TSupport-US-01
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of TSUPPORT (a Traditional Chinese Medicine) for Adults With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT05183594
- Acronym / sponsor ID
- TSupport-US-01
- Conditions
- Tourette Syndrome
- Keywords
- Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 28-week single-arm trial to evaluate the efficacy, safety and tolerability of TSupport (a Traditional Chinese Medicine) for adults with Tourette Syndrome.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSupport group | Experimental | Dietary Supplement: TSupport (a Traditional Chinese Medicine)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female adult (aged 18-65) with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- Total Tic Score (TTS) ≥ 20 on the Yale Global Tic Severity Scale (YGTSS) at screening and baseline.
- In investigator's opinion the presenting tic symptoms cause at least a moderate degree of distress or impairment.
- On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial including medications thought to effect tic symptoms.
- 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.
Key exclusion criteria (14 listed)
- 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);
- 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);
- 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.
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSupport (a Traditional Chinese Medicine)TSupport is made up of 11 Chinese medicinal herbs. | Dietary supplement | TSupport group |
Primary outcome
The change from baseline to Week 24 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS).
Time frame: Baseline, Week 24
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.
3 secondary outcomes
The change from baseline to Week 24 in YGTSS tic-related impairment (TRI) scores.
Time frame: Baseline, Week 24
Mean change from baseline to Week 24 in TS-CGI severity and improvement.
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.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Bloch, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSupport (a Traditional Chinese Medicine) in people with Tourette Syndrome, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael H Bloch, MD, PhD (203-974-7551, michael.bloch@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline to Week 24 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS). (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.