NL-OMON29120尚未招募不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 40
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Part A, correlation blood-saliva PK.
- •Healthy male or female volunteers aged 18-30 years
- •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
- •Able to perform at least 5 of the 6 NeuroCart® activities.
排除标准
- •Part A, healthy volunteers
- •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
- •Clinically meaningful blood loss (including blood donation), or a transfusion of any blood product within 12 weeks before screening.
- •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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