Bee Venom for the Treatment of Parkinson Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: bee venom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bee venom<br> | Drug: bee venom<br>* 12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.<br>* Other names: 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.;|
| Placebo Comparator: saline<br> | Drug: bee venom<br>* 12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.<br>* Other names: 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS III scores | 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Bee venom, Motor fluctuations, Disease progression