ACTRN12621000319875已完成2 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 male patients with Tourette Syndrome (TS).
oema Pharma Australia Pty Ltd0 个研究点目标入组 15 人开始时间: 2021年3月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 50 Years（—）
- 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 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. 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. 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) 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.; 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 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. 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. 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) 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.
排除标准
- •Patients who meet any of the following criteria will be excluded from study participation:
- •1.Secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism, if, in the opinion of the investigator, they will interfere with study procedures.
- •2.IQ<70.
- •Note: a previously conducted IQ level assessment can be used by the investigator and does not have to be repeated at screening for study purposes.
- •Additionally, in the absence of a formal IQ test result, the assessment that the targeted IQ level is reached can be based on the investigator’s judgment. The investigator can use proxies to IQ score such as the participant’s education level (i.e. completion of secondary school education) and/or their employment status.
- •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 with uncontrolled seizure disorders.
- •5.A history of severe traumatic brain injury or stroke.
- •6.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.
- •7.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.
- •8.Positive urine drug screen for cannabinoids, cocaine, or nonprescribed opiates.
- •9.Participated in any clinical trial of any investigational treatments within the past 30 days.
- •; Patients who meet any of the following criteria will be excluded from study participation:
- •1.Secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism, if, in the opinion of the investigator, they will interfere with study procedures.
- •2.IQ<70.
- •Note: a previously conducted IQ level assessment can be used by the investigator and does not have to be repeated at screening for study purposes.
- •Additionally, in the absence of a formal IQ test result, the assessment that the targeted IQ level is reached can be based on the investigator’s judgment. The investigator can use proxies to IQ score such as the participant’s education level (i.e. completion of secondary school education) and/or their employment status.
- •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 with uncontrolled seizure disorders.
- •5.A history of severe traumatic brain injury or stroke.
- •6.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.
- •7.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.
- •8.Positive urine drug screen for cannabinoids, cocaine, or nonprescribed opiates.
- •9.Participated in any clinical trial of any investigational treatments within the past 30 days.
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