Bee Venom for the Treatment of Parkinson Disease (MIREILLE)
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ClinicalTrials.gov Identifier: NCT01341431 |
Recruitment Status :
Completed
First Posted : April 25, 2011
Last Update Posted : June 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: bee venom | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: bee venom |
Drug: bee venom
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Other Names:
|
Placebo Comparator: saline |
Drug: bee venom
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Other Names:
|
- UPDRS III scores [ Time Frame: 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.
- 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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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341431
France | |
Centre d'Investigation Clinique ICM | |
Paris, France, 75013 |
Principal Investigator: | Andreas Hartmann, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01341431 |
Other Study ID Numbers: |
P090102 |
First Posted: | April 25, 2011 Key Record Dates |
Last Update Posted: | June 16, 2014 |
Last Verified: | June 2013 |
Parkinson disease Bee venom Motor fluctuations Disease progression |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |