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

NCT ID: NCT05183594

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TSupport (a Traditional Chinese Medicine)

Intervention Type: DIETARY_SUPPLEMENT

TSupport is made up of 11 Chinese medicinal herbs.

Interventions

TSupport (a Traditional Chinese Medicine)

TSupport is made up of 11 Chinese medicinal herbs.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Bloch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Child Study Center

New Haven, Connecticut, United States

Countries

United States

Central Contacts

Michael H Bloch, MD, PhD

Role: CONTACT

michael.bloch@yale.edu

203-974-7551

James F Leckman, MD, PhD

Role: CONTACT

James.leckman@yale.edu

203-785-7971

Facility Contacts

Michael H Bloch, MD, PhD

Role: primary

michael.bloch@yale.edu

203-974-7551

James F Leckman, MD, PhD

Role: backup

James.leckman@yale.edu

203-785-7971

Other Identifiers

TSupport-US-01

Identifier Type: -

Identifier Source: org_study_id