Bee Venom for the Treatment of Parkinson Disease (MIREILLE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: bee venom

Study type: Interventional

Funder types: Other

Identifiers

NCT01341431

P090102

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

bee venom

Experimental group

Treatment:

Drug: bee venom

saline

Placebo Comparator group

Treatment:

Drug: bee venom