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Bee Venom for the Treatment of Parkinson Disease (MIREILLE)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bee venom
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Bee venom, Motor fluctuations, Disease progression

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre d'Investigation Clinique ICM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bee venom

saline

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group
changes in L-Dopa equivalence doses over 12 months
Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN
Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV

Full Information

First Posted
March 30, 2011
Last Updated
June 13, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01341431
Brief Title
Bee Venom for the Treatment of Parkinson Disease
Acronym
MIREILLE
Official Title
Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Bee venom, Motor fluctuations, Disease progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bee venom
Arm Type
Experimental
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bee venom
Other Intervention Name(s)
1: Experimental : Bee venom, 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.
Intervention Description
12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
Primary Outcome Measure Information:
Title
UPDRS III scores
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group
Time Frame
one year
Title
changes in L-Dopa equivalence doses over 12 months
Time Frame
1 year
Title
Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN
Time Frame
one year
Title
Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV
Time Frame
> 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Hartmann, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation Clinique ICM
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27403743
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. Erratum In: PLoS One. 2016;11(9):e0162937.
Results Reference
derived
PubMed Identifier
26571268
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.
Results Reference
derived

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Bee Venom for the Treatment of Parkinson Disease

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