EUCTR2018-000100-41-ES进行中（未招募）1 期
A Randomized, Placebo-Controlled Study of ABX-1431 in Adult Patients with Tourette Syndrome or Chronic Motor Tic Disorder - Tourette Syndrome Titration Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Patient is a male or female = 18 to 64 years of age at the Screening Visit.
- •b. Patient has a diagnosis of TS or CMTD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- •c. Patient’s YGTSS-TTS results must be = 22 (range 0- 50) at the Baseline/Randomization Visit.
- •d. At the Baseline/Randomization Visit patients must be taking a stable drug regimen for tics and comorbidities for 30 days and must be expected to remain on a stable drug regimen during this study. Patients receiving no medication for TS may participate. Patients who have recently discontinued medication for tics must have discontinued them for at least 30 days. For neuroleptic drugs (e.g. risperidone, aripiprazole), the minimum discontinuation period is 30 days prior to the Baseline/Randomization Visit. For injectable depot neuroleptic drugs the minimum discontinuation period is one dosage cycle plus 14 days.
- •e. Patient is legally competent, has been informed of the nature and scope of relevance for the study, voluntarily agrees to participation, agrees to the study restrictions, and has signed the informed consent form (ICF) approved by the Ethics Review Committee (ERC).
- •f. Patients using cannabinoid medications for their tics must discontinue their use at least 14 days prior to the Baseline/Randomization Visit. The Investigator and patient must be confident that these patients will not require these medications for the duration of the study until 14 days after the last dose of study medication. Examples of cannabinoids include cannabis in any form, nabilone or ?9-tetrahydrocannabinol (THC)-containing medications such as nabiximols (Sativex®) or dronabinol. The use of recreational cannabinoids during this study is not permitted.
- •g. Female patients of child-bearing potential must have a negative pregnancy test [serum or urine human chorionic gonadotropin (hCG)] at the Screening Visit and other indicated visits. They must practice a highly effective, reliable and medically approved contraceptive regimen during the study. Post-menopausal women may enter this study. Post-menopausal women are defined as those without menses in the past 12 months, and with a serum follicle stimulating hormone (FSH) in the post-menopausal range. Women who are surgically sterile may enter this study with written documentation of the surgical procedure.
- •h. Male patients must be willing to use a condom with sexual partners during this study until 14 days after the last dose of study medication. Male patients must be willing to abstain from sperm donation for 3 months after the completion of this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Patient is taking strong inducers or inhibitors of cytochrome P450 (CYP)3A4/5 or CYP2C9.
- •b. Patient has evidence of alcohol abuse or dependence, as defined by the DSM-S criteria, with two or more of the 11 criteria at the Screening Visit or within 1 year before the Screening Visit.
- •c. Patient has evidence of drug or chemical abuse (except nicotine), as defined by the DSM-5 criteria, at the Screening Visit or within 1 year before the Screening Visit.
- •d. Patient is unwilling to comply with study restrictions including abstinence from cannabis and alcohol from the Baseline/Randomization Visit until the follow-up telephone call 14 days after the last dose of study medication.
- •e. Patients receiving ongoing psychological therapy for tics such as Habit Reversal Training or Comprehensive Behavioral Intervention for Tics are excluded.
- •f. Patient is a lactating or pregnant female, or a female who intends to become pregnant within 90 days following the last dose of study medication.
- •g. Patient has one or more of the following laboratory results at the Screening Visit:
- •- Aspartate transaminase (AST) > 3 x upper limit of normal (ULN)
- •- Alanine transaminase (ALT) > 3 x ULN
- •- Total bilirubin > 2 x ULN (unless due to Gilbert’s syndrome)
- •h. Patient has an estimated creatinine clearance less than 60 mL/minute at the Screening Visit.
- •i. Patient has a serum albumin level below the laboratory normal range at the Screening Visit, and the physician cannot rule out hepatic insufficiency based on consideration of clinical symptoms, clinical signs, and other laboratory tests.
- •j. Patient has symptomatic chronic Hepatitis B and/or Hepatitis C Virus infection.
- •k. Patient has a clinically significant abnormality on the ECG at the Screening Visit.
- •l. Patients with a history of cancer will be excluded, with two exceptions: Patients with a history of squamous or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months may be enrolled.
- •m. Patient has TS or CMTD and also has mental retardation, autism spectrum disorder (ASD), dystonia, or post-traumatic stress disorder (PTSD). Mental retardation may be defined by medical history. ASD and PTSD may be determined by medical history.
- •n. Patient has confounding medical conditions such as active infection, primary or acquired immunodeficiency, uncontrolled diabetes, clinically significant cardiac disease, clinically significant renal disease, or any suspected hepatic insufficiency.
- •o. Patient has a diagnosis of any psychiatric comorbidity such OCD, ADHD, anxiety disorder, and/or depression and has undergone a change in therapy in the 30 days before the Baseline/Randomization Visit or is in need of a change in treatment.
- •p. Patient has a history of suicidal ideation with intent to act or a plan to act, or a suicide attempt in the last 3 years preceding the Baseline/Randomization Visit.
- •q. Patient has participated in an investigational study for medications with the last visit within 1 month for a non-biologic agent and 90 days for a biologic agent of the Baseline/Randomization Visit.
- •r. Patient is an employee of the investigative site or sponsor or a close relative of an employee of the investigative site.
- •s. Patient has intolerance or hypersensitivity to the investigational medicinal product, ABX-1431 or the excipients.
研究者
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