Bee Venom for the Treatment of Parkinson Disease (NCT01341431) | Clinical Trial Compass
CompletedPhase 2
Bee Venom for the Treatment of Parkinson Disease
France50 participantsStarted 2011-03
Plain-language summary
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).
Who can participate
Age range40 Years
SexALL
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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