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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

Tracking Information
First Submitted Date  ICMJE March 30, 2011
First Posted Date  ICMJE April 25, 2011
Last Update Posted Date June 16, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01341431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2011)
  • Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group [ Time Frame: one year ]
  • changes in L-Dopa equivalence doses over 12 months [ Time Frame: 1 year ]
  • Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN [ Time Frame: one year ]
  • Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV [ Time Frame: > 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bee Venom for the Treatment of Parkinson Disease
Official Title  ICMJE Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: bee venom
    Intervention: Drug: bee venom
  • Placebo Comparator: saline
    Intervention: Drug: bee venom
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
50
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2011)
40
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01341431
Other Study ID Numbers  ICMJE P090102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Hartmann, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP