Bee Venom for the Treatment of Parkinson Disease

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: bee venom

• Registration Number: NCT01341431
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Status Verified: 2013-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bee venom	bee venom	-
saline	bee venom	-

Primary Outcome Measures

Name	Time	Method
UPDRS III scores	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

Name	Time	Method
Evaluate the potential effect of bee venom on disease progression by comparing UPDRS III off scores between treated/placebo group	one year
changes in L-Dopa equivalence doses over 12 months	1 year
Correlate symptom (UPDRS III) progression with nigrostriatal denervation as measured by DaTSCAN	one year
Quantify the evolution (appearance, progression or regression) of motor fluctuations over the one year study period by UPDRS IV	> 1 year

Trial Locations

Locations (1)

Centre d'Investigation Clinique ICM; 🇫🇷 Paris, France