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

NCT ID: NCT01504178

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

duloxetine

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.

Group Type: EXPERIMENTAL

duloxetine

Intervention Type: DRUG

administration during 28 days

injection of apomorphine

Intervention Type: DRUG

injection performed at D28

injection of placebo of L-Dopa

Intervention Type: DRUG

performed at D28

positive control (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.

Group Type: PLACEBO_COMPARATOR

placebo of duloxetine

Intervention Type: DRUG

administration during 28 days

injection of apomorphine

Intervention Type: DRUG

injection performed at D28

injection of placebo of L-Dopa

Intervention Type: DRUG

performed at D28

negative control

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.

Group Type: PLACEBO_COMPARATOR

placebo of duloxetine

Intervention Type: DRUG

administration during 28 days

injection of placebo of apomorphine

Intervention Type: DRUG

performed at D28

L-Dopa

Intervention Type: DRUG

performed at D28

Interventions

duloxetine

administration during 28 days

Intervention Type: DRUG

placebo of duloxetine

administration during 28 days

Intervention Type: DRUG

injection of apomorphine

injection performed at D28

Intervention Type: DRUG

injection of placebo of apomorphine

performed at D28

Intervention Type: DRUG

L-Dopa

performed at D28

Intervention Type: DRUG

injection of placebo of L-Dopa

performed at D28

Intervention Type: DRUG

Other Intervention Names

injection of L-dopa

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Parkinson Association

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Brefel-Courbon, MD

Role: PRINCIPAL_INVESTIGATOR

Purpan hospital, Toulouse

Locations

CIC, Purpan Hospital

Toulouse, , France

Countries

France

Other Identifiers

09 303 03

Identifier Type: -

Identifier Source: org_study_id