NL-OMON52899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 - Clonazepam in ARID1B Evaluation (CARE study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 2 至 64（—）
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
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
- •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
相似试验
进行中（未招募）
1 期
Clinical trial to investigate the effects of clonazepam on patients with ARID1B-related intellectual disability.ARID1B-related intellectual disabilityEUCTR2019-003558-98-NLCentre for Human Drug Research40
已完成
不适用
Randomized, double-blind, placebo-controlled, three way crossover, double dummy, single centre study evaluating the effect of haloperidol 2 mg and lorazepam 1 mg on posturography and underlying systems involved in standing balance in 12 healthy elderly subjects.evenwichtsproblemenBalance disordersNL-OMON40805Centre for Human Drug Research12
进行中（未招募）
1 期
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSOPatients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.MedDRA version: 9.1Level: LLTClassification code 10034006Term: Parkinson's disease aggravatedEUCTR2005-001006-12-CZAxxonis Pharma GmbH60
进行中（未招募）
1 期
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSOPatients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.MedDRA version: 9.1Level: LLTClassification code 10034006Term: Parkinson's disease aggravatedEUCTR2005-001006-12-DEAxxonis Pharma GmbH60
进行中（未招募）
不适用
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSOPatients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.EUCTR2005-001006-12-ATAxxonis Pharma GmbH60