Parkinson Disease
Conditions
Keywords
Parkinson disease, Bee venom, Motor fluctuations, Disease progression
Brief 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).
Detailed description
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).
Interventions
DRUGbee venom
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UPDRS III scores | 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. |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed