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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
The treatment period (11 weeks) will be divided into three periods:
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):
Level 2 (from D6 to D10):
Level 3 (from D11to D15):
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR oxycodone | Experimental | A titration phase of two weeks, in three steps: Level 1 (from D1 to D5):
Level 2 (from D6 to D10):
Level 3 (from D11to D15):
|
|
| levodopa | Active Comparator | A titration phase of two weeks, in three steps: Level 1 (from D1 to D5):
Level 2 (from D6 to D10):
Level 3 (from D11to D15):
|
|
| Placebo | Placebo Comparator | A titration phase of two weeks, in three steps: Level 1 (from D1 to D5):
Level 2 (from D6 to D10):
Level 3 (from D11to D15):
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PR Oxycodone | Drug | PR Oxycodone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Average pain intensity | Change in average pain rated on visual analog scale (VAS) intensity between baseline and after 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal pain intensity | Change of maximal pain intensity over the preceding week rated on the VAS | 8 weeks |
| Functional impact of pain" of the Brief Pain Inventory (BPI) | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria relating to MRI:
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| Name | Affiliation | Role |
|---|---|---|
| Christine BREFEL-COURBON, MD | University Hospital, Toulouse | Principal Investigator |
| Claire THALAMAS, MD | University Hospital, Toulouse | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Aix-en-Provence | Aix-en-Provence | 13616 | France | |||
| CHU Amiens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38850081 | Result | Brefel-Courbon C, Harroch E, Marques A, Devos D, Thalamas C, Rousseau V, Ory-Magne F, Fabbri M, Maltete D, Rouaud T, Drapier S, Tir M, Thobois S, Salhi H, Corvol JC, Castelnovo G, Lagha-Boukbiza O, Fluchere F, Frismand S, Ansquer S, Sommet A, Rascol O. Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial. Mov Disord. 2024 Sep;39(9):1533-1543. doi: 10.1002/mds.29878. Epub 2024 Jun 8. | |
| 35148289 |
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|
| Levodopa | Drug | Levodopa |
|
|
| Oxycodone Placebo | Drug | Placebo of PR Oxycodone |
|
| Levodopa placebo | Drug |
|
| 8 weeks |
| Neuropathic Pain Symptoms Inventory (NPSI) | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| McGill pain questionnaire (SFMPQ) | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Depression and anxiety: the Hospital Depression and Anxiety (HAD) scale | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Apathy: the Lille Apathy Rating Scale (LARS) | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Fatigue : the Parkinson fatigue scale | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Sleep : the Pittsburgh sleep quality index | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Motor assessment and motor fluctuations: MDS UPDRS (MDS Movement Disorder Society - UPDRS Unified Parkinson Disease Rating Scale) | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Quality of life: Parkinson's Disease Questionnaire 39 items (PDQ-39) | Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment) | 8 weeks |
| Acetaminophen consumption reported in diary | number of pills or capsules reported in patients diary | 8 weeks |
| Adverse events | Adverse events, evaluated with an open-ended questionnaire | Day 5, Day 10, Day 15, Day 43, Day 71, Day 79 |
| changes in Resting-state brain network (3T fMRI) | changes in resting-state cerebral networks between Day 0 and Day 71, as assessed by 3T fMRI. | Day 0 /Day 71(Day 71= 8 weeks of treatment) |
| Amiens |
| 80054 |
| France |
| University Hospital of Bordeaux | Bordeaux | 33076 | France |
| University Hospital of Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Henri Mondor Hospital | Créteil | 94010 | France |
| University Hospital of Lille | Lille | 59037 | France |
| University Hospital of Limoges | Limoges | 87042 | France |
| Hospital Pierre Wertheimer | Lyon | France |
| University Hospital of Marseille | Marseille | 13385 | France |
| University Hospital of Nancy | Nancy | France |
| University Hospital of Nantes | Nantes | France |
| University Hospital of Nîmes - Caremeau | Nîmes | France |
| Pitié-Salpêtrière Hospital | Paris | 75651 | France |
| University Hospital of Poitiers | Poitiers | 86021 | France |
| University Hospital of Rennes | Rennes | 35033 | France |
| University Hospital of Rouen | Rouen | 76031 | France |
| University Hospital of Strasbourg | Strasbourg | 67098 | France |
| Chu Toulouse | Toulouse | 31059 | France |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| C005177 | benserazide, levodopa drug combination |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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