Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- UPDRS III scores
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee venom on motor symptoms of Parkinson's disease over a period of one year, also the potential effects of this treatment on disease progression compared to placebo (saline injections).
详细描述
The investigators plan to assess the potential efficacy of repeated (monthly) injections of bee venom on the motor symptoms of Parkinson disease over a period of one year. The investigators will also assess the potential effects of this treatment on disease progression. All assessments will be conducted in comparison to placebo (saline injections).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Parkinson disease according to the Parkinson's Disease Society Brain Bank criteria (Hughes et al., 1992)
- •Age > 40 ans (exclusion of juvenile forms)
- •Hoehn and Yahr stage 1,5-3 off
- •Pathological DaTSCAN
- •MRI excluding atypical or secondary forms of parkinsonism
- •Negative testing to bee venom (intradermoreaction)
- •Affiliated to the French Social Security System
排除标准
- •Parkinson disease Hoehn & Yahr stage < 1,5 or > 3
- •Positive intradermoreaction to bee venom
- •IgE positive to bee venom
- •Known allergy to bee venom
- •Contra-indications to treatment with bee venom (Alyostal®)
- •Atypical or secondary parkinsonian syndrome (verified by MRI)
- •Treatment with antipsychotics over the past 6 months
- •Cardiac, hepatic or renal failure
- •Normal DaTSCAN
- •Contra-indications to MRI scanning
- •Pregnancy
- •Major depression or other severe acute/ongoing psychiatric disorder
- •Cognitive impairment (MMS >24)
- •Patient under guardianship
研究组 & 干预措施
bee venom
干预措施: bee venom (Drug)
saline
干预措施: bee venom (Drug)
结局指标
主要结局
UPDRS III scores
时间窗: one year
Quantify the magnitude of a potential long-term symptomatic effect of bee venom by comparing UPDRS III scores at study inclusion and the final visit one year later before and after bee venom injection.
次要结局
- Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group(one year)
- changes in L-Dopa equivalence doses over 12 months(1 year)
- Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN(one year)
- Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV(> 1 year)