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

Parkinson's Disease Clinical Trial

— DOULOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504178
• Other study ID #: 09 303 03
• Status: Completed
• Phase: Phase 3
• First received: December 30, 2011
• Last updated: February 21, 2017
• Start date: May 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• duloxetine
administration during 28 days
• placebo of duloxetine
administration during 28 days
• injection of apomorphine
injection performed at D28
• injection of placebo of apomorphine
performed at D28
• L-Dopa
performed at D28
• injection of placebo of L-Dopa
performed at D28

Locations

Country	Name	City	State
France	CIC, Purpan Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	French Parkinson Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective pain threshold determined using thermal stimulations (thermotest) with the method of levels	Before duloxetine intake and after one month of chronic duloxetine intake	One month
Secondary	Objective pain threshold determined recording the nociceptive reflex of flexion	Before duloxetine intake and after one month of chronic duloxetine intake	One month
Secondary	Clinical evaluation of the severity of the motor handicap of patients using the Unified Parkinson's Disease Rating Scale (UPDRS III)	Before duloxetine intake and after one month of chronic duloxetine intake	One month