Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2011-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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bee venom
bee venom
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
saline
bee venom
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Interventions
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bee venom
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Andreas Hartmann, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Centre d'Investigation Clinique ICM
Paris, , France
Countries
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References
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Hartmann A, Mullner J, Meier N, Hesekamp H, van Meerbeeck P, Habert MO, Kas A, Tanguy ML, Mazmanian M, Oya H, Abuaf N, Gaouar H, Salhi S, Charbonnier-Beaupel F, Fievet MH, Galanaud D, Arguillere S, Roze E, Degos B, Grabli D, Lacomblez L, Hubsch C, Vidailhet M, Bonnet AM, Corvol JC, Schupbach M. Bee Venom for the Treatment of Parkinson Disease - A Randomized Controlled Clinical Trial. PLoS One. 2016 Jul 12;11(7):e0158235. doi: 10.1371/journal.pone.0158235. eCollection 2016.
Maurice N, Deltheil T, Melon C, Degos B, Mourre C, Amalric M, Kerkerian-Le Goff L. Bee Venom Alleviates Motor Deficits and Modulates the Transfer of Cortical Information through the Basal Ganglia in Rat Models of Parkinson's Disease. PLoS One. 2015 Nov 16;10(11):e0142838. doi: 10.1371/journal.pone.0142838. eCollection 2015.
Other Identifiers
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P090102
Identifier Type: -
Identifier Source: org_study_id
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