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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: bee venom Phase 2

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 Design
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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

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Arms and Interventions
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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:
  • 1: Experimental : Bee venom
  • 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group [ Time Frame: one year ]
  2. changes in L-Dopa equivalence doses over 12 months [ Time Frame: 1 year ]
  3. Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN [ Time Frame: one year ]
  4. Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV [ Time Frame: > 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
France
Centre d'Investigation Clinique ICM
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Andreas Hartmann, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01341431     History of Changes
Other Study ID Numbers: P090102
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson disease
Bee venom
Motor fluctuations
Disease progression

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases