Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's D… (NCT02601586) | Clinical Trial Compass
CompletedPhase 2/3
Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease
France67 participantsStarted 2016-09
Plain-language 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
Who can participate
Age range40 Years – 75 Years
SexALL
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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 s…