NCT00524914

Brief Summary

Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations. We suppose that painful symptoms could be related to the neurotransmitter deficit of PD. So, we would like to evaluate the involvement of dopaminergic system in nociceptive processing in PD patients. The objectives of this study is to assess and to compare the effect of a dopamine agonist administration on the nociceptive threshold and on the cerebral activity using positrons emission tomography (PET scan) in two groups of PD patients (in 16 painful PD patients and in 16 pain free PD patients). We hypothesise that dopamine agonist could normalise nociceptive threshold and cerebral activity which were both abnormal in PD patients. Moreover, we think that painful PD patients could be more improved by dopamine agonist than pain free PD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

4 months

First QC Date

September 4, 2007

Last Update Submit

April 10, 2008

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasePainNociceptive thresholdFunctional imagingCerebral activityDopamine agonist.

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of this study is subjective nociceptive threshold using thermotest. We determinate thermal nociceptive threshold using a Peltier- based contact temperature stimulation device with a contact thermode.

    the primary outcome is measured after acute administration of apomorphine ( after 30 minutes )

Secondary Outcomes (2)

  • Objective nociceptive threshold using the nociceptive flexion reflex (RIII) which can be elicited by a nociceptive electrical stimulation to the sural nerve and recorded in the ipsilateral Biceps Femoris muscle.

    after acute administration of apomorphine

  • Cerebral activity using H215O PET analysis of regional Cerebral Blood Flow (rCBF) on subjects while they received alternate randomized noxious (defined as pain threshold) and innocuous stimuli.

    After administration of apomorphine

Study Arms (2)

1

EXPERIMENTAL

Apomorphine

Drug: apomorphine

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

apomorphineDRUG

Acute apomorphine subcutaneous 3 mg

1
placeboDRUG

placebo subcutaneous

2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from Parkinson's disease
  • PD patients with a Hoehn et Yahr \< à 3 (Hoehn et Yahr 1967)
  • PD patients treated by dopaminergic drugs (levodopa, dopamine agonist, IMAO-B, ICOMT…)
  • Painful PD patients : PD patients suffering from chronic pain (\> 3 months) which is related to PD and suggests neuropathic pain
  • Pain free PD patients : PD patients without any pain related to PD.

You may not qualify if:

  • Patients with chronic disease resulting in chronic pain (severe arthosis….)
  • PD patients with a Hoehn et Yahr stage \> 3 (Hoehn et Yahr 1967)
  • Patients with cancer
  • Patients who underwent a PET scan in the last three months
  • Pregnancy
  • Patients with a contra indication of use of apomorphine or domperidone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie

Toulouse, Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson DiseasePain

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AporphinesBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • Christine BREFEL-COURBON, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

FR(1)