Bee Venom for the Treatment of Parkinson Disease (MIREILLE)

Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: bee venom

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Centre d'Investigation Clinique ICM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 1: Experimental : Bee venom; 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.
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: 1: Experimental : Bee venom; 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPDRS III scores	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.	one year

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Andreas Hartmann, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General Publications

• 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. Erratum In: PLoS One. 2016;11(9):e0162937.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 22, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Estimate): June 16, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Parkinson disease; Disease progression; Motor fluctuations; Bee venom
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P090102