Overview
Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease
Status:
Recruiting
Recruiting
Trial end date:
2021-09-01
2021-09-01
Target enrollment:
0
0
Participant gender:
All
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 periodPhase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, ToulouseTreatments:
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