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

NCT03564132 | Completed Phase 2

• 1 other identifier: CMUH106-REC2-148
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tourette Disorder; Tic Disorders

Keywords

Yigansan; YGTSS

Outcome Measures

Primary Outcomes (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.

  Baseline to Week4

Secondary Outcomes (3)

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

  Baseline to Week 4

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

  Baseline to Week 4

• Response Rate

  Week 4

Study Arms (2)

Yigansan

EXPERIMENTAL

2.5g of Yigansan granules by mouth, three times a day for 4 weeks

Drug: Yigansan

Placebo

PLACEBO COMPARATOR

2.5g of Placebo(contained one-tenth Yigansan) granules by mouth, three times a day for 4 weeks

Drug: Placebo

Interventions

Yigansan DRUG

Yigansan granules

Also known as: YGS

Yigansan

Placebo DRUG

One-tenth concentration of Yigansan manufactured to mimic Yigansan granules

Also known as: Placebo (for Yigansan)

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (12)

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

  PMID: 11642235 BACKGROUND

• 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.

  PMID: 23206664 BACKGROUND

• 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.

  PMID: 23006968 BACKGROUND

• 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.

  PMID: 20233526 BACKGROUND

• 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.

  PMID: 24507013 BACKGROUND

• 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.

  PMID: 21053620 BACKGROUND

• 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.

  PMID: 23572168 BACKGROUND

• 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.

  PMID: 26072932 BACKGROUND

• 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.

  PMID: 21339906 BACKGROUND

• 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.

  PMID: 27042075 BACKGROUND

• 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.

  PMID: 25954314 BACKGROUND

• 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.

  PMID: 24923986 BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Cheng-Hao Huang

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 20, 2018
• Study Start: June 16, 2018
• Primary Completion: August 15, 2020
• Study Completion: August 31, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)