EUCTR2014-005452-26-NO进行中（未招募）1 期
A randomized, placebo controlled, double-blind, double-dummy, 3-period cross-over study in adult patients with autism spectrum disorders evaluating cognitive response, eye-gaze, and heart rate variability after single-dose oxytocin 8 or 24 IU intranasal administration using the OptiNose bi-directional nose-to-brain device.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- OptiNose AS
- 入组人数
- 18
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
- Male
入选标准
- •1. Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis.
- •2. Subjects must be in good general health, as determined by the investigator. ?
- •3. Subject’s pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator.
- •4. Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.?
- •5. Provision of a signed, written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects showing major septal deviation or a significantly altered nasal epithelium. ?
- •2. Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs. ?
- •3. Subjects with current significant nasal congestion due to common colds. ?
- •4. Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder. ?
- •5. Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent)
- •6. Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
- •7. History of significant drug or alcohol abuse (as per WHO AUDIT/DUDIT criteria). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study. ?
- •8. Abnormal laboratory values which is deemed clinically significant by investigator. ?
- •9. Full scale IQ < 75 (due to the prerequisite ability to complete self report measures). ?
- •10. Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate. ?
- •11. Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
- •12. Other unspecified reasons that, in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.
研究者
相似试验
进行中（未招募）
不适用
A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a.Active rheumatoid arthritis, functional class II-IIIMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2008-001241-26-HUBiotest AG110
进行中（未招募）
不适用
A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant MethotrexateEUCTR2008-001241-26-BGBiotest AG110
进行中（未招募）
1 期
Study to investigate the efficacy and safety of allo-APZ2-CVU on wound healing of therapy-resistant chronic venous ulcer (CVU).Chronic venous ulcers (CVU)MedDRA version: 21.1Level: LLTClassification code 10066677Term: Chronic leg ulcerSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2020-004960-24-DERHEACELL GmbH & Co. KG200
招募中
1 期
A double-blind, randomized, placebo-controlled, dose-finding phase II study to assess the efficacy and safety of pasireotide s.c. in patients with Post-Bariatric HypoglycaemiaCTIS2023-505316-37-00Recordati AG72
进行中（未招募）
1 期
A double-blind, randomized, placebo-controlled, dose finding study of R126638 given as a single or repeat dose in oral solution vs placebo in the treatment of pityriasis versicolor. - Dose finding study of R126638 in pityriasis versicolorEUCTR2005-004852-11-SEBarrier Therapeutics Inc.144