Bee Venom for the Treatment of Parkinson Disease

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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