CTIS2024-512949-17-00进行中（未招募）1 期
A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults with Tourette Syndrome - SCI-021-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •TS according to DSM-5, Male and female subjects with an age between =18 and =65 years, Total tic score (TTS) of the YGTSS-R >14, 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 a 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., Male subjects must be willing to use a condom with sexual partners during this study and for a period of three months following the last administration of study medication until the follow-up visit. Male subjects must be willing to abstain from sperm donation for 3 months after the completion of this study.
排除标准
- •Comorbid OCD, ADHD, depression, and anxiety disorder when unstable and/or in need of an initial adjustment for a therapy, Use of cannabis or CBM in the 30-day period prior to study entry and/or positive delta-9-THC urine test at baseline, Positive urine beta-hCG pregnancy test, Pregnant or breast-feeding women, Subjects who received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug or to use an investigational device during the course of the study, Subjects with a known allergy, hypersensitivity, or intolerance to the active substances and excipients of study medication (e.g., cannabis, cannabinoids, etc.), Any condition, which in the opinion of the investigator, would interfere with the evaluation of the study product or poses a health risk to the subject, Subjects who are employees of the sponsor or employees or close relatives of the investigator, Presence of comorbid psychiatric conditions: developmental disability, psychotic illness and bipolar disorder, Ongoing behavioural treatment for tics, History of schizophrenia, seizure, psychotic, severe personality, or pervasive developmental disorder, Current clinical diagnosis of substance abuse or dependence, History of or current cannabis dependence, Secondary and other chronic tic disorders or other significant neurological disorders, Known severe cardiac diseases, known severe cardiovascular diseases, known positive for human immunodeficiency virus (HIV), known hepatitis C, known hepatitis B, or other severe hepatic and renal disorders by history, Concomitant medications have to be on stable dose since at least 6 weeks before entering the study and must be well tolerated at baseline without causing dizziness, confusion, sedation, or somnolence such as central nervous system depressants (e.g., antipsychotics, barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants)
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