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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Nov 9, 2015

Keywords

ClinConnect Summary

The treatment period (11 weeks) will be divided into three periods:

1. A titration phase of two weeks, during which of the doses of the treatments will be gradually increased in three steps:

Level 1 (from D1 to D5):
* Oxycodone: 10 mg PR/day bid (5 mg PR/5 mg PR)
* Levodopa: 100 mg/day bid (50 mg/50 mg)

Level 2 (from D6 to D10):
* Oxycodone: 20 mg PR/day tid (10 mg/0 mg/10 mg)
* Levodopa: 150 mg/day tid (50 mg/50 mg/50 mg)

Level 3 (from D11to D15):
* Oxycodone: 40 mg PR/day tid (20 mg/0 mg/20 mg)
* Levodopa: 200 mg/day tid (100 mg/50 mg/50 mg)
2. A fixed dose ...

Gender

ALL

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