- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524914
Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study (APODOUL)
Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations. Painful complaints with various description (muscle cramps, painful dystonia, aching, numbness, tingling, burning, vibrating, lancinating) are described and can or cannot be related to motor symptoms. Physiopathology of pain in PD is discussed. It has been suggested that the occurrence of painful symptoms could be in part due to central modification of nociception and basal ganglia damage and the dopaminergic deficit would be expected to eliminate the inhibitory influence on thalamic nociceptive activity. Recently, data have shown that PD patient had a lower nociceptive threshold than healthy volunteers. Our team has reported that levodopa administration normalised this nociceptive threshold and decreased cerebral activity measured with positrons emission tomography (PET- H215O during experimental nociceptive stimulation) in several nociceptive cortical areas which were overactive in PD. These findings suggest that central dopamine system plays an important part in the control of the nociceptive pathways in PD. Nevertheless, in the central nervous system, levodopa could be converted in dopamine but also in noradrenaline modulating noradrenergic system. In order to confirm the involvement of dopaminergic system in nociceptive processing in PD, we would like to assess a specific drug of dopamine system (a dopamine agonist, apomorphine) in PD patients.
The primary objective of this study is to assess the effect of dopamine agonist acute administration versus placebo on the nociceptive subjective threshold in two groups of PD patients (painful PD patients, n =16 and pain free PD patients, n = 16). This is a controlled cross over, double blind, randomised study.
The secondary objectives are to assess and to compare the apomorphine effect on the objective nociceptive threshold (nociceptive flexion reflex) and on the activation of cerebral areas using functional imaging (TEP- H215O) during experimental nociceptive stimulation in the two groups of PD patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Toulouse, France, 31059
- Service de Neurologie
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
placebo subcutaneous
|
Experimental: 1
Apomorphine
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Acute apomorphine subcutaneous 3 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: the primary outcome is measured after acute administration of apomorphine ( after 30 minutes )
|
the primary outcome is measured after acute administration of apomorphine ( after 30 minutes )
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: after acute administration of apomorphine
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after acute administration of apomorphine
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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.
Time Frame: After administration of apomorphine
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After administration of apomorphine
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine BREFEL-COURBON, PhD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- 0602308
- PHRC 2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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