Bee Venom for the Treatment of Parkinson Disease

NCT ID: NCT01341431

Last Updated: 2014-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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).

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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bee venom

Group Type EXPERIMENTAL

bee venom

Intervention Type DRUG

12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.

saline

Group Type PLACEBO_COMPARATOR

bee venom

Intervention Type DRUG

12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.

Interventions

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bee venom

12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.

Intervention Type DRUG

Other Intervention Names

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1: Experimental : Bee venom 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Hartmann, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Centre d'Investigation Clinique ICM

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27403743 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26571268 (View on PubMed)

Other Identifiers

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P090102

Identifier Type: -

Identifier Source: org_study_id

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