Bee Venom for the Treatment of Parkinson Disease - Full Text View

Purpose

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	Intervention	Phase
Parkinson Disease	Drug: bee venom	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider) Primary Purpose: Treatment
Official Title:	Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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:

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 ]


Enrollment:	50
Study Start Date:	March 2011
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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).

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 History of Changes
Other Study ID Numbers:	P090102
Study First Received:	March 30, 2011
Last Updated:	June 13, 2014

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

ClinicalTrials.gov processed this record on May 25, 2017

Bee Venom for the Treatment of Parkinson Disease (MIREILLE)