Trial | NCT01504178  Report issue

Official Title

Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    duloxetine levodopa apomorphine ...

  • Study Participants

    28
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.
Study Started
May 31
2011
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Feb 23
2017

Drug duloxetine

administration during 28 days

Drug placebo of duloxetine

administration during 28 days

Drug injection of apomorphine

injection performed at D28

Drug injection of placebo of apomorphine

performed at D28

Drug L-Dopa

performed at D28

  • Other names: injection of L-dopa

Drug injection of placebo of L-Dopa

performed at D28

duloxetine Experimental

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.

positive control (L-Dopa) Placebo Comparator

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.

negative control Placebo Comparator

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.

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
No Results Posted