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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Centre d'Investigation Clinique ICM
Paris, France
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.
Time frame: one year
Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group
Time frame: one year
changes in L-Dopa equivalence doses over 12 months
Time frame: 1 year
Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN
Time frame: one year
Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV
Time frame: > 1 year
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