EUCTR2019-003558-98-NL进行中（未招募）1 期
Randomized, double-blind, placebo-controlled, two way crossover, single centre study evaluating the acute and chronic effect of clonazepam on cognitive tests and patient-reported outcome measures in patients with ARID1B-related intellectual disability. - Clonazepam in ARID1B Evaluation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Part A, saliva PK.
- •Healthy male or female volunteers
- •Informed consent provided by volunteer
- •Part B, ARID1B patients.
- •Informed consent provided by both parents, or the legal guardian prior to any study mandated procedure.
- •Known mutation in ARID1B
- •Assent provided by the participant.
- •Aged 6 years or older
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disorder that could interfere with saliva production.
- •Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
- •Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year.
- •History or clinical evidence of any disease and/or existence of a surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •History of severe respiratory problems or severe liver- or renal insufficiency.
- •Other medical or psychosocial history making the participant unsuitable for participation as determined by the treating paediatrician.
- •History or clinical evidence of alcoholism within the 3-year period prior to screening (i.e. regular use of more than 21 units of alcohol/week).
- •Clinically significant findings on physical examination.
- •Medications with a strong influence on CYP3A4 metabolism
- •Subjects with a BMI > 30 and/or cardiovascular, respiratory or immune system disorders
- •Part B, ARID1B patients.
- •Clear indication of not wanting to participate during the study
- •Use of benzodiazepines or any other medication or drug with the potential to influence study related endpoints in the investigator’s opinion (including e.g. CYP3A4-related drugs).
- •Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
- •History of severe respiratory problems or severe liver- or renal insufficiency.
- •Other medical or psychosocial history making the participant unsuitable for participation as determined by the treating paediatrician.
研究者
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