A Randomized, Placebo Controlled, Double-blind, 3-period Cross-over Study in Adult Patients With Autism Spectrum Disorders Evaluating Cognitive Response After Single- Dose Oxytocin 8 or 24 IU Intranasal Administration Using the OptiNose Bi-directional Nose-to-brain Device
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- OptiNose AS
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Performance on an emotion sensitivity test
研究概览
简要总结
Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity.
The primary objective of this study is to identify any differences between a single dose of 8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be measured in terms of performance on cognitive tests and physiological markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis.
- •Subjects must be in good general health, as determined by the investigator.
- •Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator.
- •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
- •Provision of a signed, written informed consent.
排除标准
- •Subjects showing major septal deviation or a significantly altered nasal epithelium.
- •Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs.
- •Subjects with current significant nasal congestion due to common colds.
- •Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- •Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent)
- •Systemic illness requiring treatment within 2 weeks prior to Study Day
- •History of significant drug or alcohol abuse (as per WHO Alcohol use disorder identification test and drug use disorder identification test criteria) Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
- •Abnormal laboratory values which is deemed clinically significant by investigator.
- •Full scale IQ < 75 (due to the prerequisite ability to complete self report measures).
- •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.
- •Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
- •Other unspecified reasons that, in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.
研究组 & 干预措施
Placebo
Placebo delivered with the OptiNose Breath Powered Bi directional liquid device
干预措施: Placebo (Drug)
8IU intranasal oxytocin
8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
干预措施: 8IU intranasal oxytocin (Drug)
8IU intranasal oxytocin
8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
干预措施: OptiNose Breath Powered Bi (Device)
24IU intranasal oxytocin
24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
干预措施: 24IU intranasal oxytocin (Drug)
24IU intranasal oxytocin
24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device
干预措施: OptiNose Breath Powered Bi (Device)
Placebo
Placebo delivered with the OptiNose Breath Powered Bi directional liquid device
干预措施: OptiNose Breath Powered Bi (Device)
结局指标
主要结局
Performance on an emotion sensitivity test
时间窗: 45 mins after oxytocin/placebo administration
Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).
Performance on a facial emotion morphing task
时间窗: 45 mins after oxytocin/placebo administration
Participants will complete a task evaluating faces that morph into different emotional expressions.
次要结局
- Performance on the reading the mind in the eyes test(45 mins after oxytocin/placebo administration)
- Performance on an emotional dot probe task(45 mins after oxytocin/placebo administration)
- Heart rate variability(40 minutes after oxytocin/placebo administration)
- Eyetracking(45 mins after oxytocin/placebo administration)