Clinical trial NCT01341431: Bee Venom for the Treatment of Parkinson Disease
Official title: Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson disease
Bee venom
Motor fluctuations
Disease progression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: UPDRS III scores
timeFrame: one year
Secondary outcomes:
measure: Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group
timeFrame: one year
measure: changes in L-Dopa equivalence doses over 12 months
timeFrame: 1 year
measure: Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN
timeFrame: one year
measure: Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV
timeFrame: > 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique ICM
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Andreas Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.