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

NCT05183594 | Unknown

• 1 other identifier: TSupport-US-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tourette Syndrome

Keywords

Tourette Syndrome

Outcome Measures

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.

  Baseline, Week 24

Secondary Outcomes (3)

• The change from baseline to Week 24 in YGTSS tic-related impairment (TRI) scores.

  Baseline, Week 24

• Mean change from baseline to Week 24 in TS-CGI severity and improvement.

  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.

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

Study Arms (1)

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.

Dietary Supplement: TSupport (a Traditional Chinese Medicine)

Interventions

TSupport (a Traditional Chinese Medicine) DIETARY_SUPPLEMENT

TSupport is made up of 11 Chinese medicinal herbs.

TSupport group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michael H Bloch, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael H Bloch, MD, PhD

CONTACT

203-974-7551; michael.bloch@yale.edu

James F Leckman, MD, PhD

CONTACT

203-785-7971; James.leckman@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 10, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)