EUCTR2021-004424-15-DE进行中（未招募）1 期
An open-label, Phase IIa, multi-center, 12-week prospective study to evaluate the safety and efficacy of NOE-105 at a daily dose range of 2.5mg to 15mg in adult and adolescent male patients with Tourette Syndrome (TS). - An OL Phase IIa study to evaluate NOE-105 in adults and adolescents with Tourette Syndrome
oema Pharma Australia Pty Ltd0 个研究点目标入组 18 人开始时间: 2021年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- 性别
- Male
入选标准
- •1. Ability and willingness to provide written informed consent and to comply with the study procedures.
- •2. Fluency in the language of the investigator, study staff and the informed consent.
- •3. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •4. Have been under the care of the Investigator for at least 1 year. If not, then the Investigator should liaise closely with the patient’s clinician for the full assessment of the patient.
- •5. Male patients aged 12 to 50 years.
- •6. Meeting DSM-5 diagnostic criteria for Tourette Syndrome and requiring drug therapy.
- •7. Are in need for pharmacotherapy or are experiencing lack of benefit from their current therapy as evidenced by a CGI severity at least moderately ill or intolerance that impacts patient adherence to treatment at screening visit.
- •8. If applicable depending on the patient’s age, agreement to the following during the study treatment period and for at least 90 days after the last dose of study drug:
- •Refrain from donating sperm
- •o Must agree to use contraception as detailed below:
- •Agree to use a male condom (with female partner use of an additional highly effective contraceptive method with a failure rate of <1% per year as described in Appendix 4 Contraceptive and Barrier Requirements) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
- •Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism.
- •2. IQ<70.
- •3. Current diagnosis of bipolar disorder, schizophrenia, or Major Depressive Disorder (MDD). Patients with MDD on a stable antidepressant treatment for > 1 month can participate in the study.
- •4. Patients who, in the opinion of the investigator, are at risk of imminent self-harm or with a recent suicidal behavior (6 months prior to the study).
- •5. Patients with uncontrolled seizure disorders.
- •6. A history of severe traumatic brain injury or stroke.
- •7. Any unstable medical conditions or are currently ill (e.g., congenital heart disease, arrhythmia or cancer), which, in the investigator's judgment, will put them at a risk of major adverse event during this trial, or will interfere with safety and efficacy assessments.
- •8. Require cognitive-behavioral therapy (CBT, including habitual inversion therapy, cognitive therapy, relaxation training, etc.) during the trial period UNLESS started at least 8 weeks prior to study start.
- •9. Positive urine drug screen for cannabinoids, cocaine, or nonprescribed opiates.
- •10. Participated in any clinical trial of any investigational treatments within the past 30 days.
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