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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
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 belowSelect...
I am between 6 to 17 years old and have been diagnosed with Tourette Syndrome.
Select...
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:Select...
I have not taken depot antipsychotics in the last 3 months.
Select...
I have had neuroleptic malignant syndrome in the past.
Select...
I am currently diagnosed with major depression.
Select...
I agree to use two birth control methods or remain abstinent during and after the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, 4, 6 and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, 4, 6 and 8
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 moreTrial 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
5,432 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken VMAT2 inhibitors in the last 2 weeks.I have been on a stable dose of SSRIs for at least 4 weeks, not for Tourette's symptoms.I have not taken depot antipsychotics in the last 3 months.I am between 6 to 17 years old and have been diagnosed with Tourette Syndrome.I have had neuroleptic malignant syndrome in the past.I am not pregnant, breastfeeding, and use reliable birth control or practice abstinence.I am currently diagnosed with major depression.I haven't taken any atypical antipsychotics like Risperdal or Seroquel in the last 4 weeks.I have a history of a neurological condition with abnormal movements.I started my current brain therapy at least two months ago.I have a history of schizophrenia, bipolar, or another psychotic disorder but may have OCD or ADHD.I am not pregnant, not breastfeeding, and use reliable birth control or practice abstinence.I am between 6 to 17 years old and have been diagnosed with Tourette Syndrome.I agree to use two birth control methods or remain abstinent during and after the trial.I haven't taken antipsychotics like topiramate in the last week or levodopa/dopamine agonists in the last 2 weeks.The doctor thinks that your tic symptoms make it hard for you to do your usual daily activities.Your score on the YGTSS test is 20 or higher during screening and baseline.
Research Study Groups:
This trial has the following groups:- Group 1: T92 group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.