Central neuropathic pain in Parkinson's disease MedDRA version: 19.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Trade Name: oxycontin LP 5mg
Product Name: Oxycontin LP 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: oxycodone
CAS Number: 124-90-3
Other descriptive name: OXYCODONE HYDROCHLORIDE
Concentratio
Sponsors
UHToulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with Parkinson’s disease according to the UKPDSBB criteria -Patients aged 40 to 75 years (male or female) -Patients suffering from chronic pain (lasting for more than 3 months) -Patients suffering from central neuropathic pain caused by PD, as identified with a two-part clinical questionnaire: The first part assesses the causality of the link between PD and pain i.e. pain is considered to be related to PD if the patient reports at least three of the following five features: - Pain is chronologically related to PD (occurring at the onset of PD or influenced by motor condition) - Pain located in the half of the body most severely affected by PD (topographical relationship to PD) - Pain is influenced by dopaminergic drugs - Pain is not related to any other evident etiology (rheumatic, traumatic or orthopedic disorders) - The patient identifies a link between pain and disease The second part identifies central neuropathic pain i.e. pain is considered to be central neuropathic pain if it fulfills the two following criteria: - There is no radicular systematization - Symptoms are defined as having the clinical characteristics of neuropathic pain with the DN4 interview questionnaire -Patients with a PD-related central neuropathic pain intensity of at least 3 points on the VAS (average intensity over the last month), -Patients with both types of pain (neuropathic and nociceptive) will be included if the neuropathic pain predominates (higher intensity) -Patients treated with a stable regimen of dopaminergic drugs (levodopa and/or dopamine agonists) for at least 4 weeks before the study dan thoughout the study -Patients with a stable step 1 analgesic (NSAIDS, acetaminophen) or coanalgesic (antidepressants, antiepileptic) treatment for at least 4 weeks before the study and throughout the study -Patients with health insurance -Patients who have signed a written informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: General exclusion criteria: -Patients suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy etc.) -De Novo patients (patients never before treated with dopaminergic drugs) -Patients with intercurrent acute pain -Patients suffering from a chronic disease causing pain (rheumatoid arthritis, ankylosing spondylitis, diabetic neuropathy, cancer etc.)Patients treated with neuroleptics (clozapine, risperidone etc.) -Patients treated by deep brain stimulation -Patients with clinically detectable behavioural disorders (impulse control disorder, hallucinations, delirium) and addiction -Patients with disabling dyskinesias (items MDS-UPDRS 4.1 and 4.2 >1) -Patients with painful restless legs syndrome -Patients with cognitive impairment (MMS < 25) or unable to complete the various scales used in the study -Patients under juridical protection -Patients refusing to participate -Women pregnant, nursing or of childbearing age without effective contraception. Exclusion criteria relating to treatments: -Hypersensitivity to oxycodone, levodopa, benserazide or a combination of these drugs -Patients treated with opioid drugs (step 2 and 3) -Patients treated with non-selective monoamine oxidase inhibitors (MAOI) -Patients with severe hepatocellular insufficiency -Patients with uncontrolled cardiovascular and pulmonary diseases -Persistent constipation that has already resulted in a subocclusive state -Patients treated with antiemetic neuroleptics -Patients with angle-closure glaucoma Exclusion criteria relating to MRI: -Patients with claustrophobia -Patients with a hearing aid, cardiac prosthesis, pacemaker, surgical clip -Patients refusing to be informed of abnormalities are detected on MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the respective effects of two drugs, oxycodone and levodopa, administered over a period of 8 weeks at stable dosage, versus placebo, on PD-related central neuropathic pain intensity (average intensity over the preceding week) in PD patients. ;Timepoint(s) of evaluation of this end point: Between D0 (baseline) and D71 (after 8 weeks of treatment with a stable dose).;Secondary Objective: Evaluate : -The respective effects of oxycodone and levodopa, versus placebo, on the different components of pain through various clinical pain questionnaires -The response rates based on 30% and 50% in each groups -The use of rescue analgesic medication (acetaminophen) in the three groups -The respective effects of oxycodone and levodopa, versus placebo, on behavioral symptoms (depression, anxiety, apathy, fatigue, sleep disorders), motor symptoms and quality of life -The putative correlation between changes in motor status and variations of pain intensity - A head-to-head comparison of the effects of oxycodone versus levodopa on clinical pain parameters -The safety and tolerability of each drug The exploratory objective is to evaluate the respective effects of oxycodone and levodopa, versus placebo, on resting-state brain network changes (3T fMRI), to identify the pathophysiological mechanisms underlying the analgesic effect of each drug. ;Primary end point(s): The primary endpoint of this study is the change in average pain intensity over the preceding week, rated on a visual analog scale (VAS) (from 0 = no pain to 10 = maximal pain) between D0 (baseline) and D71 (after 8 weeks of treatment with a stable dose). Pain intensity on the VAS is a validated clinical criterion for the global assessment of both discriminative and emotional aspects of pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The secondary endpoints are evaluated between between D0 and D71. The Acetaminophen consumption and the adverse events are evaluated pending the participation of each patient.;Secondary end point(s): The secondary endpoints are: -The change in maximal pain intensity over the preceding week rated on the VAS (maximum ?VAS) between D0 and D71. -The proportion of patients experiencing at least 30% and 50% pain relief between D0 and D71 -The change in scores for various validated questionnaires of pain, behavior, quality of life and motor status between D0 and D71: - Pain: “Functional impact of pain” of the Brief Pain Inventory (BPI); Neuropathic Pain Symptoms Inventory (NPSI); McGill pain questionnaire (SF-MPQ) - Depression and anxiety: the Hospital Depression and Anxiety (HAD) scale - Apathy: the Lille Apathy Rating Scale (LARS) - Fatigue : the Parkinson fatigue scale - Sleep : the Pittsburg sleep quality index - Motor assessment and motor fluctuations: MDS-UPDRS - Quality of life: Parkinson’s Disease Questionnaire 39 items (PDQ-39) -Acetaminophen consumption (diary) -Adverse events, evaluated with an open-ended questionnaire -The exploratory criterion will be the changes in resting-state cerebral networks between D0 and D71, as assessed by 3T fMRI. | — |
Countries
France
Contacts
Public ContactHuguet
UHToulouse
Outcome results
None listed