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NCT Number: NCT01504178

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIC, Purpan Hospital

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

administration during 28 days

placebo of duloxetine

Drug

administration during 28 days

injection of apomorphine

Drug

injection performed at D28

injection of placebo of apomorphine

Drug

performed at D28

L-DOPA

Drug

performed at D28

Other names: injection of L-dopa

injection of placebo of L-Dopa

Drug

performed at D28

Primary outcomes

  1. Subjective pain threshold determined using thermal stimulations (thermotest) with the method of levels

    Time frame: One month

    Before duloxetine intake and after one month of chronic duloxetine intake

Secondary outcomes

  1. Objective pain threshold determined recording the nociceptive reflex of flexion

    Time frame: One month

    Before duloxetine intake and after one month of chronic duloxetine intake

  2. Clinical evaluation of the severity of the motor handicap of patients using the Unified Parkinson's Disease Rating Scale (UPDRS III)

    Time frame: One month

    Before duloxetine intake and after one month of chronic duloxetine intake

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • French Parkinson Association

Registry information

Acronym: DOULOX

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2012
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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