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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't changed my medication that could affect my tics in the last 4 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility criteria met