Bee Venom for the Treatment of Parkinson Disease (MIREILLE)

• ClinicalTrials.gov Identifier: NCT01341431
• Recruitment Status: Completed
• First Posted: April 25, 2011
• Last Update Posted: June 16, 2014
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

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).

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

• 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

Arms and Interventions

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

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

• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hartmann A, Müllner 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, Schüpbach 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01341431
• Other Study ID Numbers: P090102
• First Posted: April 25, 2011
• 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