Parkinson's Disease
Conditions
Keywords
Noradrenergic system and pain in Parkinson's disease
Brief summary
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be involved in pain alteration in PD. To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with PD. 36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. This increase would be the same than those observed with L-Dopa.
Interventions
DRUGinjection of placebo of L-Dopa
performed at D28
DRUGduloxetine
administration during 28 days
DRUGplacebo of duloxetine
administration during 28 days
DRUGinjection of apomorphine
injection performed at D28
DRUGinjection of placebo of apomorphine
performed at D28
DRUGL-Dopa
performed at D28
Sponsors
French Parkinson Association
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB * Parkinson's disease patients with a score ≤ 3 on the Hoehn and Yahr scale * Patients treated with dopaminergic antiparkinsonian drugs (L-Dopa, dopamine agonists, ICOMT…) * Patients affiliated to a social protection program * Women with efficacy contraception
Exclusion criteria
* Patients suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies…) * Parkinson's disease patients with a score \> 3 on the Hoehn and Yahr scale * Depressed patients (MADRS score \< 16) * Patients suffering from a cancer * Patients under tutelage, curatella or law protection * Patients with a complete contraindication against apomorphine injections or duloxetine administration (selective serotonin reuptake inhibitor and monoamine oxydase inhibitors) * Patients without any control of their arterial hypertension * Patients with a neuroleptic treatment * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective pain threshold determined using thermal stimulations (thermotest) with the method of levels | One month | Before duloxetine intake and after one month of chronic duloxetine intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective pain threshold determined recording the nociceptive reflex of flexion | One month | Before duloxetine intake and after one month of chronic duloxetine intake |
| Clinical evaluation of the severity of the motor handicap of patients using the Unified Parkinson's Disease Rating Scale (UPDRS III) | One month | Before duloxetine intake and after one month of chronic duloxetine intake |
Countries
France
Outcome results
None listed