Apomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in Unified Parkinson Disease Rating Scale
研究概览
简要总结
To study the effects of acute apomorphine vs. placebo administration on different Parkinson's disease pain types.
详细描述
Apomorphine is the only anti-parkinsonian agent compatible with levodopa in improving Parkinson's disease (PD) motor symptoms. Besides, it has positive effects on some of the nonmotor symptoms of the disease, such as urinary disturbances and sleep. Apomorphine is usually well tolerated as it produces limited side effects. Knowledge about the effects of apomorphine on pain in PD is scarce. Evidence on this topic has only been reported in case reports or small studies but represents a potentially important use of the drug. We hypothesize that apomorphine may be a rational, safe, and useful treatment for subjects with pain in PD, including different subtypes. Within this framework, the present study will evaluate the effect of acute apomorphine vs. placebo administration on different PD pain types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Upon entry to the study, all subjects will be assigned to a subject number. Eligible subjects will be randomized to receive either apomorphine injections or placebo on VISIT 2 in a double-blind manner according to a randomization schedule using computerized randomization tables prepared by a blinded clinical nurse. Participants will then cross over to the other treatment group to receive apomorphine or placebo injections on VISIT 3. The specific type of randomization used will be block randomization to ensure equal sample sizes of the apomorphine and placebo groups
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with PD according to the MDS Clinical diagnostic criteria for Parkinson's disease.
- •Participants on antiparkinsonian medication in advanced stages of the disease and experiencing OFF periods and pain.
- •Apomorphine treatment naïve subjects or not received any within the last six months.
- •Stable PD and pain medications for at least 30 days.
- •Competence to self-report pain severity in the King's Parkinson's disease Pain Scale and a Likert Visual Analogue Scale.
排除标准
- •Subjects who are unable to self-report pain severity in the selected scales. Patients that may require a translator or are illiterate will be included if they can self-report pain severity.
- •Subjects with a diagnosis of dementia (Montreal Cognitive Assessment <20).
- •Subject with poorly controlled orthostatic hypotension.
- •Subjects associated with another medical condition, e.g., any cardiovascular, renal or hepatic impairment, hematological or psychiatric diseases.
- •Any contraindication to receiving apomorphine injections:
- •Subjects who are hypersensitive to apomorphine or any ingredient in the formulation or component of the container (hydrochloric acid concentrated, sodium bisulfite (E222), and water)
- •Subjects using concomitant drugs of the 5HT3 antagonist class including (e.g., ondansetron, granisetron, palonosetron)
- •Subjects using concomitant antihypertensive medications or vasodilators
- •Subjects with prolonged QT on an electrocardiogram.
研究组 & 干预措施
Apomorphine Injections
干预措施: Apomorphine Injectable Solution (Drug)
Placebo Injections
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Unified Parkinson Disease Rating Scale
时间窗: 0, 1 and 2 weeks
Measures changes of symptom severity, treatment response and the efficacy of treatments. Part 1 (non-motor experiences of daily living), Part 2 (motor experiences of daily living), Part 3 (motor examination) and Part 4 (motor complications). The maximum score for all the parts is 272. Higher scores are indicative of worse outcomes.
Change in Likert Visual Analogue Scale
时间窗: 0, 1 and 2 weeks
The measure of global pain change perceived by the patients. The most simple Likert Visual Analogue Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). There are no numerical values on this scale however, a positioning towards the left of the scale indicates a worse outcome.
次要结局
- Number of adverse events(0, 1 and 2 weeks)
- Change in Clinical Global Impression Scale(0, 1 and 2 weeks)
研究者
Veronica Bruno
Clinical Assistant Professor
University of Calgary