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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Levodopa; Oxycodone

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