Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease (DOULOX)
Parkinson's Disease
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring Noradrenergic system and pain in Parkinson's disease
Eligibility Criteria
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
Sites / Locations
- CIC, Purpan Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Placebo Comparator
duloxetine
positive control (L-Dopa)
negative control
The first group (12 patients) will receive, after 28 days of duloxetine treatment, one duloxetine dose, an injection of apomorphine and a placebo of L-Dopa.
The second group (12 patients) will receive, after 28 days of placebo treatment, one placebo dose of duloxetine, an injection of apomorphine and injection of placebo of L-Dopa.
The third group will receive, after 28 days of placebo treatment, one placebo of duloxetine, an injection of placebo of apomorphine and a dose of L-Dopa.