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NCT Number: NCT01341431

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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Attributes Disease Progression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre d'Investigation Clinique ICM

Paris, 75013, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bee venom

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MIREILLE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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