NL-OMON39955招募中不适用
Open label, Single Ascending Dose, Cross-over Study to Assess the Pharmacokinetics of Circadin® (Prolonged-Release Melatonin) Mini tablets in Children with Neurodevelopmental disorders and Sleep Disturbances. - PK study of Circadin® mini-tablets in children.
eurim Pharmaceuticals Ltd.0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
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 17（—）
入选标准
- •- Subject must be 12-17 years old (extremes inclusive);
- •- Subject has a documented history of autistic spectrum disorder (ASD; as confirmed according to, DSM-IV-TR 299.00, 299.10 and 299.80 or ICD 10: F 84.0, F84.2, F84.3, F84.5, F84.9 ) or one of the following neurogenetic diseases according to ICD 10: Smith-Magenis syndrome, Angelman syndrome or Tuberous Sclerosis (Bourneville*s disease);
- •- Subject has current sleep problems; defined as difficulty initiating or maintaining sleep, or non restorative sleep, for at least 1 month (DSM-IV 307.42)
- •- Subject is able to comply with taking the study drug and collaborate freely with the study procedures;
- •- Written informed consent from parents having parental responsibility or from the legal guardian(s). In the case of a child is aged 12 years or older the written informed consent of the child is needed in addition to that of parents having responsibility/legal guardian; and
- •- Subject is able to understand instructions in Dutch.
排除标准
- •- Subject has history of difficulty with swallowing and/or easy choking;
- •- Subject has current symptoms suggestive of obstructive sleep apnea syndrome or any breathing related sleep disorders or periodic limb movements;
- •- Subject has known clinically significant disturbance(s) in hepatic and/or renal function;
- •- Subject has non-stable epileptic attacks within 3 months prior to screening, in case of a history of epilepsy;
- •- Subject who currently has asthmatic symptoms;
- •- Subject has untreated medical/psychological condition that may be the etiology of sleep disturbances;
- •- Subject is unable to refrain from the use of disallowed concomitant medication ordietary supplements (see paragraph 3.4) from 1 week prior to study days;
- •- Subject is unable to refrain from caffeine-containing products for 24 hours before each occasion;
- •- Subject has a known allergy to melatonin;
- •- Female subject who is pregnant at time of screening;
- •- Subject has unstable use of allowed medication within 2 months prior to the screening;
- •- Subject has clinically relevant periodontal disease and/or oral injuries as judged by the investigator;
- •- Subject is unable to refrain from eating bananas and chocolate during the entire day before saliva collection;
- •- Subject is unable to refrain from drinks containing artificial colorants, caffeine (including but not limited to coffee, tea, cola), or alcohol during the day of the collection;
- •- Subject is unable to refrain from aspirin or drugs that contain ibuprofen on the collection day;
- •- Participation in an investigational drug study within 90 days prior to the first dose and/or participation in more than 4 clinical trials in the last year.
研究者
相似试验
进行中（未招募）
1 期
An Open-Label, Single/Multiple Ascending Dose Study to Assess the Pharmacokinetics, Efficacy, Safety and Tolerability of Inhalation Delivery of Hydroxychloroquine Sulfate (HCQ) in Healthy Volunteers and patients with COVID-19Healthy volunteers and patients with COVID - 19MedDRA version: 23.0Level: HLTClassification code 10084510Term: Coronavirus infectionsSystem Organ Class: 100000004862EUCTR2020-003770-50-CZVšeobecná fakultní nemocnice v Praze137
进行中（未招募）
1 期
A Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant RecipientsPrevention of immune mediated allograft rejection in patients with end-stage renal disease (ESRD) who are tissue typed as HLA-A*02 negative and have received a kidney transplant from an HLA-A*02 positive living donor.MedDRA version: 21.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865EUCTR2019-001730-34-GBSangamo Therapeutics France SAS30
进行中（未招募）
1 期
A Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant RecipientsEUCTR2019-001730-34-DESangamo Therapeutics France SAS60
招募中
2 期
A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients.Allograft rejection1002766510029149Renal transplant rejectionNL-OMON56213Sangamo Therapeutics France SAS8
进行中（未招募）
1 期
A Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant RecipientsPrevention of immune mediated allograft rejection in patients with end-stage renal disease (ESRD) who are tissue typed as HLA-A*02 negative and have received a kidney transplant from an HLA-A*02 positive living donor.MedDRA version: 21.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865EUCTR2019-001730-34-BESangamo Therapeutics France SAS60