Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease
NCT ID: NCT02601586
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
67 participants
INTERVENTIONAL
2016-09-30
2020-11-30
Brief Summary
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Detailed Description
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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 period: the level 3 dose will be maintained for 8 weeks (from D16 to D71). The study treatment will be administered as an add-on therapy, with the usual antiparkinsonian treatment. If patients have side effects at the level 3 dose, a return to the level 2 dose will be authorized.
3. A withdrawal period: The dose of the study treatment will gradually be reduced, over an eight-day period:
For patients treated with the level 3 dose for 8 weeks: decrease to the level 2 dose over the first 3 days (from D72 to D74) ; then a decrease to the level 1 dose over the next 3 days (from D75 to D77). The treatment will be stopped completely on D78. The last visit will take place on D79, 2 days after the end of treatment.
For patients treated with the level 2 dose: decrease to the level 1 dose over the first 3 days (from D72 to D74), with stopping of the treatment on D75. The last visit will take place on D79, 5 days after the end of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PR oxycodone
A titration phase of two weeks, in three steps:
Level 1 (from D1 to D5):
* Oxycodone : 10 mg PR/day bid (5 mg PR/5 mg PR)
* Levodopa placebo 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 placebo: 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 placebo: 200 mg/day tid (100 mg/50 mg/50 mg)
* A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71).
* A withdrawal period:
PR Oxycodone
PR Oxycodone
Levodopa placebo
levodopa
A titration phase of two weeks, in three steps:
Level 1 (from D1 to D5):
* Oxycodone placebo : 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 placebo: 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 placebo: 40 mg PR/day tid (20 mg/0 mg/20 mg)
* Levodopa : 200 mg/day tid (100 mg/50 mg/50 mg)
* A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71).
* A withdrawal period:
Levodopa
Levodopa
Oxycodone Placebo
Placebo of PR Oxycodone
Placebo
A titration phase of two weeks, in three steps:
Level 1 (from D1 to D5):
* Oxycodone placebo : 10 mg PR/day bid (5 mg PR/5 mg PR)
* Levodopa placebo 100 mg/day bid (50 mg/50 mg)
Level 2 (from D6 to D10):
* Oxycodone placebo: 20 mg PR/day tid (10 mg/0 mg/10 mg)
* Levodopa placebo: 150 mg/day tid (50 mg/50 mg/50 mg)
Level 3 (from D11to D15):
* Oxycodone placebo: 40 mg PR/day tid (20 mg/0 mg/20 mg)
* Levodopa placebo: 200 mg/day tid (100 mg/50 mg/50 mg)
* A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71).
* A withdrawal period:
Oxycodone Placebo
Placebo of PR Oxycodone
Levodopa placebo
Interventions
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PR Oxycodone
PR Oxycodone
Levodopa
Levodopa
Oxycodone Placebo
Placebo of PR Oxycodone
Levodopa placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
* Patients with claustrophobia
* Patients with a hearing aid, cardiac prosthesis, pacemaker, surgical clip
* Patients refusing to be informed of abnormalities are detected on MRI
40 Years
75 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Christine BREFEL-COURBON, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Claire THALAMAS, MD
Role: STUDY_CHAIR
University Hospital, Toulouse
Locations
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Hospital of Aix-en-Provence
Aix-en-Provence, , France
CHU Amiens
Amiens, , France
University Hospital of Bordeaux
Bordeaux, , France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, , France
Henri Mondor Hospital
Créteil, , France
University Hospital of Lille
Lille, , France
University Hospital of Limoges
Limoges, , France
Hospital Pierre Wertheimer
Lyon, , France
University Hospital of Marseille
Marseille, , France
University Hospital of Nancy
Nancy, , France
University Hospital of Nantes
Nantes, , France
University Hospital of Nîmes - Caremeau
Nîmes, , France
Pitié-Salpêtrière Hospital
Paris, , France
University Hospital of Poitiers
Poitiers, , France
University Hospital of Rennes
Rennes, , France
University Hospital of Rouen
Rouen, , France
University Hospital of Strasbourg
Strasbourg, , France
Chu Toulouse
Toulouse, , France
Countries
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References
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Lawn T, Rukavina K, Malcangio M, Howard M, Chaudhuri KR. Response to Mylius et al. Pain. 2022 Mar 1;163(3):e496-e497. doi: 10.1097/j.pain.0000000000002445. No abstract available.
Other Identifiers
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14 7440 01
Identifier Type: -
Identifier Source: org_study_id
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