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Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease

CompletedPhase 2, Phase 3

Sponsor: University Hospital, Toulouse

Conditions: Parkinson Disease

Interventions: PR Oxycodone, Levodopa, Oxycodone Placebo, Levodopa placebo

Countries: France

This study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period

Eligibility overview

Sex: ALL

Age: 40 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with Parkinson's disease according to the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) criteria
* Patients suffering from chronic pain (lasting for more than 3 months)
* Patients suffering from central neuropathic pain caused by PD,
* 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
* Patients treated with a stable regimen of dopaminergic drugs (levodopa and/or dopamine agonists) for at least 4 weeks before the study dan throughout 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

Exclusion Criteria:

* Patients suffering from another parkinsonian syndrome
* 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
* Patients with clinically detectable behavioural disorders and addiction
* Patients with disabling dyskinesias
* Patients with painful restless legs syndrome
* Patients with cognitive impairment (MMS \< 25) or unable to complete the various scales used in the study
* 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

Locations (18)

Aix-en-Provence, France
Amiens, France
Bordeaux, France
Clermont-Ferrand, France
Créteil, France
Lille, France
Limoges, France
Lyon, France
Marseille, France
Nancy, France
Nantes, France
Nîmes, France
Paris, France
Poitiers, France
Rennes, France
Rouen, France
Strasbourg, France
Toulouse, France