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

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital

Criteria

Inclusion Criteria:

1. 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.

2. The subject meets current DSM-V diagnostic criteria for Tourette's Disorder.

3. The subject has a total score of ≥ 20 on the YGTSS at Screening and Baseline (randomization).

4. Tic symptoms may cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.

5. 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:

1. 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

2. The subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.

3. 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.

4. Subjects who ever participated in any Chinese medicine or western medicine trial within 30 days.

5. Subjects requiring cognitive-behavioral therapy (CBT) for Tourette's Disorder during the trial period.

6. The inability to swallow Chinese herbal medicine.

7. Female subjects who have been pregnant.