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Tourette DisorderPhase 2NCT03564132

Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder

A Phase 2 study testing Yigansan in people with Tourette Disorder and Tic Disorders, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Yigansan was used in Ming dynasty by Xue Kai as a remedy for restlessness and agitation in children. We expect that the total YGTSS scores of Yigansan-treated subjects will be significantly reduced compared to that of placebo-treated subjects. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Tourette Disorder, Tic Disorders
What is being tested?
Yigansan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteTaiwan
Study dates
16 Jun 2018to 31 Aug 2022
Phase
Phase 2
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

  • The subject is a male or female child or adolescent, 6 to 17 years of age (inclusive) at the time of signing the informed consent/assent.
  • The subject meets current DSM-V diagnostic criteria for Tourette's Disorder.
  • The subject has a total score of ≥ 20 on the YGTSS at Screening and Baseline (randomization).
  • Tic symptoms may cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.
  • Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative urine pregnancy test (when visiting our clinic at week 0 and week 4).

Who cannot join

  • The subject presents with a clinical presentation and/or history that is consistent with another neurologic condition that may have accompanying abnormal movements. These include, but are not limited to:
  • Transient Tic disorder/ Huntington's disease/ Parkinson's disease/ Sydenham's chorea/ Wilson's disease/ Mental retardation/ Pervasive developmental disorder/ Traumatic brain injury/ Stroke/ Restless Legs Syndrome
  • The subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.
  • Subjects who receive psychostimulants for the treatment of ADD/ADHD and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment.
  • Subjects who ever participated in any Chinese medicine or western medicine trial within 30 days.
  • Subjects requiring cognitive-behavioral therapy (CBT) for Tourette's Disorder during the trial period.
  • The inability to swallow Chinese herbal medicine.
  • Female subjects who have been pregnant.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital

    Taichung, 404

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder

Yigansan was used in Ming dynasty by Xue Kai as a remedy for restlessness and agitation in children. We expect that the total YGTSS scores of Yigansan-treated subjects will be significantly reduced compared to that of placebo-treated subjects.

Read the detailed description

Tourette's disorder (TD) is a chronic, childhood-onset neuropsychiatric disorder. It is characterized by multiple motor and vocal tics, including involuntary or semivoluntary, sudden, brief, intermittent, repetitive movements or sounds. Yigansan was used in several clinical trials, like dementia, pervasive developmental disorder, schizophrenia and Huntington's disease, with good results. So the investigators choose Yigansan as a Chinese medicine formula in this study. After the participants signed the consent form, they have to stop taking any Chinese medicine or western medicine for treating Tourette's disorder for two weeks and then are randomly assigned to Yigansan group or placebo group. Our hypothesis is that Yigansan will be expected to improve motor tics and vocal tics, and YGTSS scores will decrease after 4-weeks treatments; secondary outcomes are measured by CGI-TS (Clinical Global Impression-Tourette Syndrome) scale and GTS-QOL (The Gilles de la Tourette syndrome-quality of life scale), and the investigators will also proceed the basic research of metabolomics and biochemistry(GOT、GPT、BUN、Creatinine、K+). In order to ensure the relationship of Tourette's disorder and allergic rhinitis, the investigators will detect IgE. Besides, the investigators will collect blood and urine from every child or adolescent when a participant visits our clinic at week 0 and week 4. In order to find these biomarkers related to TD, the investigators will use ELISA kits to detect and quantitate significantly changeable concentration of cytokines associated with YGTSS scores. In addition to specific cytokine targets, the investigators will also find these metabolites involved in TD between two groups before and after taking YGS. The serum and urine samples will be prepared and subjected to LC-MS/MS analysis. In summary of the experimental designs and expected results, the therapy and background information will be more clarified on the therapeutic efficacy and safety by Yigansan treatment for TD. Most importantly, this study will provide a kind of Chinese medicine formula to relieve such a disorder that most doctors feel difficult to treat.

Being tested
Yigansan, Placebo
Keywords
Yigansan, YGTSS
Medical subject headings
Tourette Syndrome, Tic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YigansanDrug

    Also called YGS

    Yigansan granules

  • PlaceboDrug

    Also called Placebo (for Yigansan)

    One-tenth concentration of Yigansan manufactured to mimic Yigansan granules

Study groups in NCT03564132
Study groupRoleWhat they receive
YigansanExperimental2.5g of Yigansan granules by mouth, three times a day for 4 weeks
Receives: Drug: Yigansan
PlaceboPlacebo comparator2.5g of Placebo(contained one-tenth Yigansan) granules by mouth, three times a day for 4 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to Week 4 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS)

    Ratings are 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. The scores of TTS are from 0 to 50 and the scores of impairment are also from 0 to 50. Summation of TTS and impairment are YGTSS scores which will be the primary outcome measure in this trial.

    Measured: Baseline to Week4

Secondary outcomes (3)

  1. Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 4

    Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

    Measured: Baseline to Week 4

  2. Mean change from Baseline to Endpoint (Week 4) in Total YGTSS Score

    The YGTSS is used to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100).

    Measured: Baseline to Week 4

  3. Response Rate

    Clinical response is defined as > 25% improvement from baseline to Week 4 in YGTSS TTS between 2 groups or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 4.

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start16 Jun 2018
  3. Primary completion15 Aug 2020
  4. Study completion31 Aug 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03564132
Sponsor's protocol ID
CMUH106-REC2-148
Status last verified
Apr 2023
First submitted
11 Jun 2018
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jankovic J. Tourette's syndrome. N Engl J Med. 2001 Oct 18;345(16):1184-92. doi: 10.1056/NEJMra010032. No abstract available.

    PubMed 11642235

  • Cohen SC, Leckman JF, Bloch MH. Clinical assessment of Tourette syndrome and tic disorders. Neurosci Biobehav Rev. 2013 Jul;37(6):997-1007. doi: 10.1016/j.neubiorev.2012.11.013. Epub 2012 Dec 1.

    PubMed 23206664

  • Wang S, Qi F, Li J, Zhao L, Li A. Effects of Chinese herbal medicine Ningdong granule on regulating dopamine (DA)/serotonin (5-TH) and gamma-amino butyric acid (GABA) in patients with Tourette syndrome. Biosci Trends. 2012 Aug;6(4):212-8. doi: 10.5582/bst.2012.v6.4.212.

    PubMed 23006968

  • Zhao L, Li AY, Lv H, Liu FY, Qi FH. Traditional Chinese medicine Ningdong granule: the beneficial effects in Tourette's disorder. J Int Med Res. 2010 Jan-Feb;38(1):169-75. doi: 10.1177/147323001003800119.

    PubMed 20233526

  • Kim YH, Son CG, Ku BC, Lee HW, Lim HS, Lee MS. Herbal medicines for treating tic disorders: a systematic review of randomised controlled trials. Chin Med. 2014 Feb 7;9(1):6. doi: 10.1186/1749-8546-9-6.

    PubMed 24507013

  • Wu M, Xiao GH, Zhang JM, Zhang X, Ma B, Wang SX, Zhou YB, Zhang JY. Clinical research into Qufeng Zhidong Recipe used to treat 31 children with tic disorder. J Tradit Chin Med. 2010 Sep;30(3):163-70. doi: 10.1016/s0254-6272(10)60034-9.

    PubMed 21053620

  • Chou IC, Lin HC, Lin CC, Sung FC, Kao CH. Tourette syndrome and risk of depression: a population-based cohort study in Taiwan. J Dev Behav Pediatr. 2013 Apr;34(3):181-5. doi: 10.1097/DBP.0b013e3182829f2b.

    PubMed 23572168

  • Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.

    PubMed 26072932

  • Eddy CM, Rickards HE, Cavanna AE. Treatment strategies for tics in Tourette syndrome. Ther Adv Neurol Disord. 2011 Jan;4(1):25-45. doi: 10.1177/1756285610390261.

    PubMed 21339906

  • Takeyoshi K, Kurita M, Nishino S, Teranishi M, Numata Y, Sato T, Okubo Y. Yokukansan improves behavioral and psychological symptoms of dementia by suppressing dopaminergic function. Neuropsychiatr Dis Treat. 2016 Mar 15;12:641-9. doi: 10.2147/NDT.S99032. eCollection 2016.

    PubMed 27042075

  • Miyaoka T, Furuya M, Horiguchi J, Wake R, Hashioka S, Thoyama M, Murotani K, Mori N, Minabe Y, Iyo M, Ueno S, Ezoe S, Hoshino S, Seno H. Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, multicenter, double-blind, placebo-controlled trial. Evid Based Complement Alternat Med. 2015;2015:201592. doi: 10.1155/2015/201592. Epub 2015 Apr 14.

    PubMed 25954314

  • Miyaoka T, Furuya M, Horiguchi J, Wake R, Hashioka S, Tohyama M, Mori N, Minabe Y, Iyo M, Ueno S, Ezoe S, Murotani K, Hoshino S, Seno H. Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, double-blind, placebo-controlled trial (a Positive and Negative Syndrome Scale, five-factor analysis). Psychopharmacology (Berl). 2015 Jan;232(1):155-64. doi: 10.1007/s00213-014-3645-8. Epub 2014 Jun 13.

    PubMed 24923986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Yigansan in people with Tourette Disorder and Tic Disorders, run by China Medical University Hospital at 1 site in Taiwan.

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Apr 2023. 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 Taiwan. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Week 4 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) (time frame: Baseline to Week4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03564132, which also lists 12 linked publications.

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 27 Apr 2023.

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