Clinical trial NCT05183594: Evaluate the Efficacy, Safety and Tolerability of TSUPPORT for Adults With Tourette Syndrome
Official title: Pilot Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of TSUPPORT (a Traditional Chinese Medicine) for Adults With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome
Keywords: Tourette Syndrome
Lead sponsor: Tasly Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The change from baseline to Week 24 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS).
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: The change from baseline to Week 24 in YGTSS tic-related impairment (TRI) scores.
timeFrame: Baseline, Week 24
measure: Mean change from baseline to Week 24 in TS-CGI severity and improvement.
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
measure: Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS at different check points.
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Michael H Bloch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: