EUCTR2018-002877-23-AT进行中（未招募）1 期
Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD
Abteilung für Neurologie der Medizinischen Universität Innsbruck0 个研究点目标入组 76 人开始时间: 2018年12月7日最近更新:
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
- 入组人数
- 76
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
- •Inclusion criteria for participants with PD:
- •1. Age 30 – 70 years
- •3. Confirmed diagnosis of idiopathic Parkinson’s disease for at least 3 years according to the UK Brain Bank criteria
- •4. On a stable regimen of anti-parkinson medication (such as L-Dopa, Amantadine, Anticholinergics, COMT inhibitors, dopamine agonists and MAO-B inhibitors) for at least three weeks prior to screening and willing to continue the same doses and regimens during study participation
- •5. Any other current and allowed prescription/ non prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least three weeks prior to screening, and participants must be willing to continue the same doses and regimens during study participation
- •6. Able and willing to sign a current IRB-approved informed consent form
- •7. Acceptable method of contraception
- •Inclusion criteria for healthy controls:
- •1. Participants without PD or significant neurological disorder
- •2. Age 30 - 70 years
- •4. Able and willing to sign a current IRB-approved informed consent form
- •5. Acceptable method of contraception
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Exclusion criteria for participants with PD:
- •1. Participants taking prostaglandins and/or vasoconstrictors/sympathomimetics (eg. COPD/asthma medication such as salbutamol, fenoterol; inotropics such as dobutamin; rhinitis therapy such as ephedrine), as oxytocin can interact with these drugs
- •2. Current or recent (within 30 days or 5 half-times of the IMP, prior to screening) participation in another study with an investigational medicinal product
- •3. Known allergy or hypersensitivity to any component of the IMPs
- •4. Females
- •5. Atypical or secondary parkinsonism (such as vascular Parkinsonism, drug induced Parkinsonism, Wilson’s disease, Alzheimer’s disease and Creutzfeld-Jacob disease)
- •6. Known abnormality in CT or MRI brain imaging which is considered to cause neurological symptoms or deficits
- •7. Concurrent dementia defined by MMSE =24
- •8. Presence of an acute or chronic major psychiatric disorder (e.g., hallucinations, agitation, paranoia)
- •9. History of severe cardiac disease (Angina, myocardial infarction, atrial fibrillation or cardiac surgery in the preceding two years)
- •10. History of end stage kidney or liver disease
- •11. Any other uncontrolled disease or any disease considered relevant by the investigator
- •12. Nicotine consumption of more than 10 cigarettes per day
- •13. Known allergy or hypersensitivity to latex rubber, due to possible cross-reactions
- •14. Patient is legally incapacitated or persons held in an institution by legal or official order
- •15. Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
- •Exclusion Criteria for healthy controls:
- •1. Participants taking prostaglandins and/or vasoconstrictors/sympathomimetics (eg. COPD/asthma medication such as salbutamol, fenoterol; inotropics such as dobutamin; rhinitis therapy such as ephedrine), as oxytocin can interact with these drugs
- •2. Current or recent (within 30 days or 5 half-times of the IMP, prior to screening) participation in another study with an investigational medicinal product
- •3. Known allergy or hypersensitivity to any component of the IMPs
- •4. Females
- •5. Any known neurological disease
- •6. Known abnormality in CT or MRI brain imaging which is considered to cause neurological symptoms or deficits
- •7. Concurrent dementia defined by MMSE =24
- •8. Presence of an acute or chronic major psychiatric disorder (e.g., hallucinations, agitation, paranoia)
- •9. History of severe cardiac disease (Angina, myocardial infarction, atrial fibrillation or cardiac surgery in the preceding two years)
- •10. History of end stage kidney or liver disease
- •11. Any other uncontrolled disease or any disease considered relevant by the investigator
- •12. Nicotine consumption of more than 10 cigarettes per day
- •13. Known allergy or hypersensitivity to latex rubber, due to possible cross-reactions
- •14. Personality change (eg. increased aggression potential, irritability, at risk for substance abuse disorder/impulsive-compulsive behavior)
- •15. Participantis legally incapacitated or persons held in an institution by legal or official order
- •16. Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
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