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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, 4, 6 and 8
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new medication for Tourette Syndrome in children.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The mean change from baseline to week 8 in total tic score (TTS) of Yale Global Tic Severity Scale (YGTSS).
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Tasly Pharmaceuticals, Inc.Lead Sponsor
22 Previous Clinical Trials
5,425 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

Frequently Asked Questions

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

Does this clinical experiment accept participants above the age of four decades?

"This trial is open to those aged 6-17; however, there are more trials available for minors (381) than the elderly (992)."

Answered by AI

Do I meet the criteria for taking part in this experiment?

"For successful enrolment in this clinical trial, individuals must possess Tourette syndrome and be between the ages of 6 to 17. Approximately 150 participants are needed to complete the study."

Answered by AI

Are there any available slots to join this clinical trial?

"Clinicaltrials.gov reveals that this trial, posted on the 1st of May 2022 and updated lastly on October 1st 2022, is no longer enrolling patients. Nevertheless, there are 1405 other clinical studies actively recruiting participants currently."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Yale Child Study Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome
2022. "A Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05188274.
All > Tourette Syndrome
~51 spots leftby Apr 2025
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