Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes on global perceived effect scale
研究概览
简要总结
Skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently and interfere with the absorption of apomorphine. The histopathology of apomorphine-induced skin reactions is poorly understood. Therefore treatment options are limited and suggestive.
Objective: to investigate the efficacy of four treatments including massage, dilution of apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous administered hydrocortisone, in Parkinson's disease patients with apomorphine-induced skin reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male subjects aged ≥30;
- •Diagnosis of idiopathic Parkinson's disease of >3 years' duration, defined by the United Kingdom (UK) Brain Bank criteria, with the exception of >1 affected relative being allowed, without any other known or suspected cause of Parkinsonism (Gibb & Lees, 1988);
- •Treatment with continuous subcutaneous apomorphine infusion;
- •Having apomorphine-induced skin reactions (i.e. erythema, swelling and/or nodule formation);
- •Male and female patients must be compliant with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study, if sexually active;
- •Subjects considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgement of the investigator.
排除标准
- •High suspicion of other parkinsonian syndromes;
- •History of respiratory depression;
- •Hypersensitivity to hydrocortisone or any excipients of the medicinal product;
- •Concomitant therapy with histamine antagonist;
- •Known with Cushing's disease or hypercortisolism
- •Any medical condition that is likely to interfere with an adequate participation in the study including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months;
- •Pregnant and breastfeeding women;
- •Current infectious disease with fever at the time of investigation.
研究组 & 干预措施
Massage with a spiky ball
Subjects are instructed to massage the apomorphine-induced skin reactions with a spiky ball 3 times a day for 2 minutes for 14 days.
干预措施: Massage with a spiky ball (Device)
Hydrocortisone cream 1%
Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.
干预措施: Hydrocortisone cream 1% (Drug)
Subcutaneous hydrocortisone 10mg
Subjects are instructed to administer subcutaneous hydrocortisone (Solu-Cortef 10mg) prior to apomorphine via the subcutaneous infusion line which is used for administration of apomorphine, for 14 days.
干预措施: Subcutaneous hydrocortisone 10mg (Drug)
Apomorphine 0.25% (2.5mg/ml)
Subjects are instructed to dilute apomorphine 0.5% (5mg/ml) with the same volume of physiologic saline (NaCl 0.9%) to 0.25% (2.5mg/ml). Apomorphine will be infused subcutaneously for 14 days.
干预措施: Apomorphine 0.25% (2.5mg/ml) (Drug)
结局指标
主要结局
Changes on global perceived effect scale
时间窗: 14 days
次要结局
- Eosinophilia(14 days)
- Personal or family history of atopic constellation(14 days)
- Changes in histological skin tissue characteristics(14 days)
- Changes in nodule size (diameter)(14 days)
- Changes in erythema size (diameter)(14 days)
- Personal or family history of allergies(14 days)