NCT01341431

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started Mar 2011

Typical duration for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

March 30, 2011

Last Update Submit

June 13, 2014

Conditions

Parkinson Disease

Keywords

Parkinson diseaseBee venomMotor fluctuationsDisease progression

Outcome Measures

Primary Outcomes (1)

  • UPDRS III scores

    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.

    one year

Secondary Outcomes (4)

  • 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

Study Arms (2)

bee venom

EXPERIMENTAL
Drug: bee venom

saline

PLACEBO COMPARATOR
Drug: bee venom

Interventions

bee venomDRUG

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

Also known as: 1: Experimental : Bee venom, 2: Placebo Comparator : NaCl 0.9%, 1 milliliter s.c.
bee venomsaline

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from Parkinson disease according to the Parkinson's Disease Society Brain Bank criteria (Hughes et al., 1992)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique ICM

Paris, 75013, France

Location

Related Publications (2)

  • 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.

    PMID: 27403743DERIVED

  • 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.

    PMID: 26571268DERIVED

MeSH Terms

Conditions

Parkinson DiseaseDisease Progression

Interventions

Bee Venoms

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthropod VenomsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Andreas Hartmann, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 25, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 16, 2014

Record last verified: 2013-06

Locations

FR(1)