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

NCT01504178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

injection of placebo of L-Dopa

performed at D28

Sponsors & Collaborators

  • French Parkinson Association

    collaborator UNKNOWN

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Christine Brefel-Courbon, MD · Purpan hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504178 on ClinicalTrials.gov