Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder
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|ClinicalTrials.gov Identifier: NCT03564132|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tourette Disorder Tic Disorders||Drug: Yigansan Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 16, 2018|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2021|
2.5g of Yigansan granules by mouth, three times a day for 4 weeks
Other Name: YGS
Placebo Comparator: Placebo
2.5g of Placebo(contained one-tenth Yigansan) granules by mouth, three times a day for 4 weeks
One-tenth concentration of Yigansan manufactured to mimic Yigansan granules
Other Name: Placebo (for Yigansan)
- Change from Baseline to Week 4 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) [ Time Frame: Baseline to Week4 ]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.
- Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 4 [ Time Frame: Baseline to 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.
- Mean change from Baseline to Endpoint (Week 4) in Total YGTSS Score [ Time Frame: Baseline to Week 4 ]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).
- Response Rate [ Time Frame: Week 4 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564132
|Contact: Cheng-Hao Huang||886-4-22052121 ext firstname.lastname@example.org|
|China Medical University Hospital||Recruiting|
|Taichung, Taiwan, 404|
|Contact: Cheng-Hao Huang, M.D. 886-4-22052121 ext 1391 email@example.com|
|Sub-Investigator: I-Ching Chou|
|Sub-Investigator: Ching-Liang Hsieh|
|Sub-Investigator: Ming-Yu Wang|
|Sub-Investigator: Der-Yen Lee|
|Principal Investigator:||Cheng-Hao Huang||China Medical University Hospital|