CompletedPhase 2

Bee Venom for the Treatment of Parkinson Disease

France50 participantsStarted 2011-03

Plain-language 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).

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

UPDRS III scores

Timeframe: one year

Trial details

NCT IDNCT01341431

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.