SCI-110 in the Treatment of Tourette Syndrome

Inclusion criteria

• . Tourette syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
• . Male and female subjects with an age between ≥18 and ≤65 years
• . Total tic score (TTS) of the revised Yale Global Tic Severity Scale (YGTSS-R) \>14
• . Clinical Global Impression-Severity Score (CGI-S) ≥4
• . Medication (and stimulation parameters for deep brain stimulation) for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study and subject must consent to maintain the stable dose during the study
• . Signed written informed consent and willingness to comply with treatment and follow-up procedures
• . Subjects capable of understanding the investigational nature, potential risks and benefits of the clinical study
• . Women of child-bearing potential must have a negative pregnancy test (e.g., urine human chorionic gonadotropin \[hCG\]) before first treatment with study medication. They must practice a highly effective, reliable and medically approved contraceptive regimen during the study (e.g., theoretical failure rate less than 1% per year as when used consistently and correctly), which include oral or parenteral or implanted hormonal contraception, vaginal ring releasing hormonal contraception (e.g., Nuvaring), intrauterine device or intrauterine system. Women without childbearing potential may enter this study. Women without childbearing potential defined as follows:

Exclusion criteria