Tourette Syndrome in ChildrenNCT05188274
A Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome
A study testing T92 in people with Tourette Syndrome in Children and Tourette Syndrome in Adolescence, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A 12-week clinical study to evaluate the safety and efficacy of T92 in pediatric patients with Tourette Syndrome. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tourette Syndrome in Children, Tourette Syndrome in Adolescence
- What is being tested?
- T92
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
- TTS ≥ 20 on the YGTSS at screening and baseline.
- In the Investigator's opinion the presenting tic symptoms caused impairment in the subject's normal daily routines.
- Females of childbearing potential had a negative pregnancy test, practiced acceptable double-barrier methods of contraception (or abstinence), and were not pregnant or lactating.
- Written informed assent or consent provided by the subject, and written informed consent provided by the parent(s)/guardians(s), as appropriate per the IRB/EC.
- In the opinion of the Investigator, the subject and designated guardian(s) and/or parent(s) must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Who cannot join
- Medical history consistent with another neurologic condition that may have had accompanying abnormal movements (e.g., Huntington's disease, Parkinson's disease, Sydenham's chorea, Wilson's disease, Mental retardation, Traumatic brain injury, Stroke, Restless legs syndrome)
- History of schizophrenia, bipolar disorder, or other psychotic disorder; Comorbid conditions such as: Obsessive Compulsive Disorder (OCD) and Attention Deficit Hyperactivity Disorder (ADHD) can be included.
- Active major depression disorder.
- History of neuroleptic malignant syndrome.
- Subjects who have had treatment with:
- investigational medication within 3 months of starting study
Show all 22Show fewer
- depot antipsychotics within 3 months of starting study
- Antipsychotics with possible effects on TS symptoms: i.e., topiramate within 1 week; levodopa or dopamine agonists within 2 weeks prior to baseline.
- VMAT2 inhibitors within 2 weeks prior to baseline.
- Atypical antipsychotics within 4 weeks: this class include risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), ziprasidone (Zeldox), paliperidone (Invega), aripiprazole (Abilify) and clozapine (Clozaril).
- Selective serotonin reuptake inhibitors unless the dosage has been stable for a minimum of 4 weeks prior to study start and not prescribed to relieve the neurological signs of TS.
- Sexually active males or females who would not commit to utilizing 2 of the approved birth control methods or who would not remain abstinent during the trial and for 90 days (males) or 30 days (females) following the last dose of investigational product.
- CBIT need to be started at least two months at screening. Could continue on existing therapy or stop it based on PI's opinion.
- Significant psychoactive substance use disorder within the past 3 months; or the urine drug screen was positive.
- Significant lab abnormality:
- Platelets ≤ 75,000/mm3
- Hemoglobin ≤ 9 g/dl
- Neutrophils, absolute ≤ 1000/mm3
- Aspartate transaminase (AST) > 3×ULN (upper limit of normal)
- Alanine aminotransferase (ALT) > 3×ULN
- Creatinine ≥ 2 mg/dl
- History or presence of any clinically important medical condition that, in the judgment of the investigator, is likely to deteriorate, could be detrimental to the subject, or could affect the subject's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
Michael H Bloch, MD, PhD, 203-974-7551, michael.bloch@yale.edu
James F Leckman, MD, PhD, 203-785-7971, james.leckman@yale.edu
About this study
Official title: A Multicenter, Randomized, Double-blind, and Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome
A 12-week clinical study to evaluate the safety and efficacy of T92 in pediatric patients with Tourette Syndrome.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, outpatient clinical study designed to evaluate the efficacy and safety of T92 in Tourette Syndrome pediatric patients.
This trial consists of a screening/wash-out period of up to 6 weeks, an 8-week supportive care period and a 4-week follow-up period for all subjects who completed the study. For the first two weeks, the patients will continue to take T92 at half dose and the T92 administration will be stopped from week 3 of the follow-up period.
Subjects will be randomly assigned to receive T92 or matching placebo based on individual body weight. The calculated amount of investigational product (T92 or placebo) will be administrated orally twice daily. Morning dose and evening dose should be administrated at about the same time every day and irrelevant to meals.
- Being tested
- T92, Placebo
- Keywords
- Tourette Syndrome
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T92Dietary supplement
T92 granules (5g/sachet) will be taken BID for 8 weeks, the dosage will be calculated by individual's body weight.
PlaceboDietary supplement
The placebo matched to T92 granules will be taken BID for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| T92 group | Experimental | The dose of T92 was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks Receives: Dietary Supplement: T92 |
| Placebo group | Placebo comparator | The dose of placebo was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change from baseline to week 8 in total tic score (TTS) of Yale Global Tic Severity Scale (YGTSS).
The Yale Global Tic Severity Scale (YGTSS) is a semi-structured clinical interview for assessing the severity of tics in children and adults. The YGTSS enables evaluations of number, frequency, intensity, complexity, and interference of motor and phonic tics, covering the past week. Each domain is scored on a 6-point scale (range 0-5) with a separate rating for "overall impairment" regarding the subject's daily life and activities. YGTSS-TTS is the sum of the total motor tic score plus the total phonic tic score ranging from 0-50. Higher scores indicate greater severity/worse outcome. Changes in TTS after 8 weeks of supportive care duration will be compared between the T92 and placebo groups.
Measured: Baseline, Week 8
Secondary outcomes (6)
The change from baseline to Week 8 in total Yale Global Tic Severity Scale (YGTSS) scale YGTSS tic-related impairment (TRI) score at week 8
The YGTSS ranking of impairment (YGTSS-TRI), with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. Higher scores indicate greater severity/worse outcome.
Measured: Baseline, Week 8
Mean change from baseline to TS-CGI severity and improvement at week 8
The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. Lower scores indicate better quality of life. Mean score was calculated with T92 and placebo group, on week 2, 4, 6, and 8.
Measured: Baseline, Week 2, 4, 6 and 8
Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS score at different check points.
Clinical response defined as a ≥ 30% reduction from baseline on TTS at week 2, 4, 6 and 8. The clinical response rate is the proportion of subjects who achieve clinical response.
Measured: Baseline, Week 2, 4, 6 and 8
Evaluation of T92 in reducing severity of the sensations before the emergence of tics by comparing the change in PUTS scores at week 8 from baseline.
The PUTS is a nine-item self-reported scale that measures the sensations before the emergence of tics, and each item is scored from 1 to 4. The total score (range: 9-36) is obtained by summing all of the nine items. Higher scores indicate greater severity/worse symptoms.
Measured: Baseline, Week 4 and 8
Evaluation of T92 in reducing severity of obsessions and compulsion occurring by comparing the change in CY-BOCS scores at week 8 from baseline.
The CY-BOCS is assessing the severity of obsessions and compulsion occurring over the past week. OCD severity score (range 0-40) including all 10 items rated on a 5-point Likert scale (range 0-4). Higher scores indicate greater severity/worse symptoms.
Measured: Baseline, Week 4 and 8
Evaluation of T92 in reducing severity of ADHD symptoms.
The ADHD-RS-IV is an 18-item scale based on the DSM-IV-TR criteria for ADHD that provides a rating of the severity of symptoms. The first 9 items assess inattentive symptoms and the last 9 items assess hyperactive-impulsive symptoms. Scoring is based on a 4-point Likert-type severity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Higher scores indicate greater severity/worse symptoms.
Measured: Baseline, Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study startMay 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette Syndrome in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Bloch, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188274
- Sponsor's protocol ID
- T92-US-01
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, and Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of T92 in Pediatric Patients With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT05188274
- Acronym / sponsor ID
- T92-US-01
- Keywords
- Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12-week clinical study to evaluate the safety and efficacy of T92 in pediatric patients with Tourette Syndrome.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, outpatient clinical study designed to evaluate the efficacy and safety of T92 in Tourette Syndrome pediatric patients.
This trial consists of a screening/wash-out period of up to 6 weeks, an 8-week supportive care period and a 4-week follow-up period for all subjects who completed the study. For the first two weeks, the patients will continue to take T92 at half dose and the T92 administration will be stopped from week 3 of the follow-up period.
Subjects will be randomly assigned to receive T92 or matching placebo based on individual body weight. The calculated amount of investigational product (T92 or placebo) will be administrated orally twice daily. Morning dose and evening dose should be administrated at about the same time every day and irrelevant to meals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T92 group | Experimental | Dietary Supplement: T92The dose of T92 was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThe dose of placebo was calculated based on body weight, orally twice daily. Supportive care duration: 8 weeks |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
- TTS ≥ 20 on the YGTSS at screening and baseline.
- In the Investigator's opinion the presenting tic symptoms caused impairment in the subject's normal daily routines.
- Females of childbearing potential had a negative pregnancy test, practiced acceptable double-barrier methods of contraception (or abstinence), and were not pregnant or lactating.
- Written informed assent or consent provided by the subject, and written informed consent provided by the parent(s)/guardians(s), as appropriate per the IRB/EC.
Key exclusion criteria (22 listed)
- Medical history consistent with another neurologic condition that may have had accompanying abnormal movements (e.g., Huntington's disease, Parkinson's disease, Sydenham's chorea, Wilson's disease, Mental retardation, Traumatic brain injury, Stroke, Restless legs syndrome)
- History of schizophrenia, bipolar disorder, or other psychotic disorder; Comorbid conditions such as: Obsessive Compulsive Disorder (OCD) and Attention Deficit Hyperactivity Disorder (ADHD) can be included.
- Active major depression disorder.
- History of neuroleptic malignant syndrome.
- Subjects who have had treatment with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T92T92 granules (5g/sachet) will be taken BID for 8 weeks, the dosage will be calculated by individual's body weight. | Dietary supplement | T92 group |
| PlaceboThe placebo matched to T92 granules will be taken BID for 8 weeks. | Dietary supplement | Placebo group |
Primary outcome
The mean change from baseline to week 8 in total tic score (TTS) of Yale Global Tic Severity Scale (YGTSS).
Time frame: Baseline, Week 8
The Yale Global Tic Severity Scale (YGTSS) is a semi-structured clinical interview for assessing the severity of tics in children and adults. The YGTSS enables evaluations of number, frequency, intensity, complexity, and interference of motor and phonic tics, covering the past week. Each domain is scored on a 6-point scale (range 0-5) with a separate rating for "overall impairment" regarding the subject's daily life and activities. YGTSS-TTS is the sum of the total motor tic score plus the total phonic tic score ranging from 0-50. Higher scores indicate greater severity/worse outcome. Changes in TTS after 8 weeks of supportive care duration will be compared between the T92 and placebo groups.
6 secondary outcomes
The change from baseline to Week 8 in total Yale Global Tic Severity Scale (YGTSS) scale YGTSS tic-related impairment (TRI) score at week 8
Time frame: Baseline, Week 8
Mean change from baseline to TS-CGI severity and improvement at week 8
Time frame: Baseline, Week 2, 4, 6 and 8
Clinical response rate, defined as a ≥ 30% reduction from baseline on TTS score at different check points.
Time frame: Baseline, Week 2, 4, 6 and 8
Evaluation of T92 in reducing severity of the sensations before the emergence of tics by comparing the change in PUTS scores at week 8 from baseline.
Time frame: Baseline, Week 4 and 8
Evaluation of T92 in reducing severity of obsessions and compulsion occurring by comparing the change in CY-BOCS scores at week 8 from baseline.
Time frame: Baseline, Week 4 and 8
Evaluation of T92 in reducing severity of ADHD symptoms.
Time frame: Baseline, Week 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Bloch, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T92 in people with Tourette Syndrome in Children and Tourette Syndrome in Adolescence, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael H Bloch, MD, PhD (203-974-7551, michael.bloch@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change from baseline to week 8 in total tic score (TTS) of Yale Global Tic Severity Scale (YGTSS). (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.