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Dietary Supplement

T92 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 children and adolescents aged 6 to 17 years upon screening with a Diagnosis of Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
Females of childbearing potential had a negative pregnancy test, practiced acceptable double-barrier methods of contraception (or abstinence), and were not pregnant or lactating
Must not have
Subjects who have had treatment with depot antipsychotics within 3 months of starting study
History of neuroleptic malignant syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, 4, 6 and 8
Awards & highlights

Summary

This trial tests a new medication called T92 to see if it helps children with Tourette Syndrome. The medication aims to reduce involuntary movements and sounds.

Who is the study for?
This trial is for boys and girls aged 6-17 with Tourette Syndrome, who experience significant disruption in daily life due to tics. Participants must be likely to follow the study plan and finish the trial. Girls able to have children must not be pregnant or breastfeeding and agree to use birth control.
What is being tested?
The study tests T92 against a placebo over 12 weeks, aiming to see if it's safe and effective for reducing Tourette Syndrome symptoms in kids. Patients won't know if they're getting T92 or the placebo.
What are the potential side effects?
While specific side effects of T92 are not listed here, clinical trials typically monitor for any negative reactions ranging from mild (like headaches or nausea) to severe (like allergic reactions). Parents will be informed about potential risks before agreeing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 to 17 years old and have been diagnosed with Tourette Syndrome.
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I am not pregnant, not breastfeeding, and use reliable birth control or practice abstinence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken depot antipsychotics in the last 3 months.
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I have had neuroleptic malignant syndrome in the past.
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I am currently diagnosed with major depression.
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I agree to use two birth control methods or remain abstinent during and after the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, 4, 6 and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, 4, 6 and 8 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 mean change from baseline to week 8 in total tic score (TTS) of Yale Global Tic Severity Scale (YGTSS).
Secondary study objectives
Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS score at different check points.
Evaluation of T92 in reducing severity of ADHD symptoms.
Evaluation of T92 in reducing severity of obsessions and compulsion occurring by comparing the change in CY-BOCS scores at week 8 from baseline.
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: T92 groupExperimental Treatment1 Intervention
The dose of T92 was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks
Group II: Placebo groupPlacebo Group1 Intervention
The dose of placebo was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks

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Who is running the clinical trial?

Tasly Pharmaceuticals, Inc.Lead Sponsor
22 Previous Clinical Trials
5,432 Total Patients Enrolled
2 Trials studying Tourette Syndrome
613 Patients Enrolled for Tourette Syndrome
Michael H Bloch, MD, PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Tourette Syndrome
10 Patients Enrolled for Tourette Syndrome

Media Library

Placebo (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05188274 — N/A
Tourette Syndrome Research Study Groups: T92 group, Placebo group
Tourette Syndrome Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05188274 — N/A
Placebo (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05188274 — N/A
~45 spots leftby Sep 2025
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