Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Diso… (NCT03564132) | Clinical Trial Compass
CompletedPhase 2
Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder
Taiwan38 participantsStarted 2018-06-16
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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:
✕. 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.
What they're measuring
1
Change from Baseline to Week 4 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS)