ISRCTN11225608已完成4 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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34811788/ (added 30/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Part A: healthy volunteers
- •1. Healthy male or female volunteers aged 18-30 years.
- •2. Informed consent provided by volunteer.
- •Part B: ARID1B patients.
- •1. Informed consent provided by both parents, or the legal guardian prior to any study mandated procedure.
- •2. Known mutation in ARID1B.
- •3. Assent provided by the participant.
- •4. Aged 6 years or older.
排除标准
- •Part A: healthy volunteers
- •1. Disorder that could interfere with saliva production.
- •2. Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
- •3. Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year.
- •4. 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.
- •5. History of severe respiratory problems or severe liver- or renal insufficiency.
- •6. Other medical or psychosocial condition or history making the participant unsuitable for participation.
- •7. 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).
- •8. Clinically significant findings on physical examination.
- •9. Medications with a strong influence on CYP3A4 metabolism.
- •10. Clinically meaningful blood loss (including blood donation), or a transfusion of any blood product within 12 weeks before screening.
- •Part B: ARID1B patients.
- •1. Clear indication of not wanting to participate during the study.
- •2. 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).
- •3. Known hypersensitivity to clonazepam, other benzodiazepines or other excipients of the study medication.
- •4. History of severe respiratory problems or severe liver- or renal insufficiency.
- •5. Other medical or psychosocial condition or history making the participant unsuitable for participation as determined by the treating physician or general practitioner.
研究者
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