← Back to Search

Traditional Chinese Medicine

TSupport for Tourette Syndrome

N/A

Waitlist Available

Led By Michael H Bloch, MD, PhD

Research Sponsored by Tasly Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female adult (aged 18-65) with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2, 4, 6, 8, 10, 12, 16, 20 and 24

Awards & highlights

Study Summary

This trial found that TSupport is an effective, safe and tolerable treatment for adults with Tourette Syndrome.

Who is the study for?

Adults aged 18-65 with Tourette Syndrome, experiencing significant tic symptoms that cause distress or impairment. Participants must have stable psychiatric medication for at least 4 weeks prior and agree to use double-barrier contraception methods. Excludes those with other neurological conditions, recent medication changes affecting tics, or significant substance use disorder.Check my eligibility

What is being tested?

The trial is testing TSupport, a Traditional Chinese Medicine, over a period of 28 weeks to see if it's effective and safe for adults with Tourette Syndrome. It's a single-arm study where all participants receive the treatment without comparison to another group.See study design

What are the potential side effects?

While specific side effects are not listed here, traditional Chinese medicines like TSupport may potentially cause digestive issues, allergic reactions, headaches or dizziness among others depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old and have been diagnosed with Tourette Syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2, 4, 6, 8, 10, 12, 16, 20 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2, 4, 6, 8, 10, 12, 16, 20 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, 4, 6, 8, 10, 12, 16, 20 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The change from baseline to Week 24 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS).

Secondary outcome measures

Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS at different check points.

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

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TSupport groupExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tasly Pharmaceuticals, Inc.Lead Sponsor

22 Previous Clinical Trials

5,565 Total Patients Enrolled

2 Trials studying Tourette Syndrome

753 Patients Enrolled for Tourette Syndrome

Michael H Bloch, MD, PhDPrincipal InvestigatorYale University

1 Previous Clinical Trials

150 Total Patients Enrolled

1 Trials studying Tourette Syndrome

150 Patients Enrolled for Tourette Syndrome

Media Library

TSupport (Traditional Chinese Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT05183594 — N/A

Tourette Syndrome Research Study Groups: TSupport group

Tourette Syndrome Clinical Trial 2023: TSupport Highlights & Side Effects. Trial Name: NCT05183594 — N/A

TSupport (Traditional Chinese Medicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05183594 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I register to participate in this experiment?

"This research project is in search of 10 participants who suffer from Tourette syndrome, aged between majority and 65. The essential qualifications for enrolment include: being male or female adult; having a DSM-V diagnosis of TS; being on a consistent pharmacological regimen for the four weeks leading up to commencement; experiencing moderate discomfort due to tics; yielding at least 20 points on YGTSS tests during screening and baseline visits; and displaying an attitude that suggests they are likely to comply with protocol requirements as well as complete the study."

Answered by AI

Are there any prospective participants being added to this experiment?

"The clinical trial registry on clinicialtrials.gov indicates that this research is not presently seeking participants. Initially posted at the start of March, 2022 and updated in July of the same year, 1404 other trials are currently recruiting patients for various studies."

Answered by AI