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Parkinson DiseasePhase 2/3OXYDOPANCT02601586

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

A Phase 2/3 study testing PR Oxycodone and Levodopa in people with Parkinson Disease, run by University Hospital, Toulouse at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
PR Oxycodone and Levodopa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
18 sitesFrance
Study dates
Sep 2016to Nov 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Hospital of Aix-en-Provence

    Aix-en-Provence, 13616

  • CHU Amiens

    Amiens, 80054

  • University Hospital of Bordeaux

    Bordeaux, 33076

  • University Hospital of Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Henri Mondor Hospital

    Créteil, 94010

  • University Hospital of Lille

    Lille, 59037

  • University Hospital of Limoges

    Limoges, 87042

  • Hospital Pierre Wertheimer

    Lyon

  • University Hospital of Marseille

    Marseille, 13385

  • University Hospital of Nancy

    Nancy

  • University Hospital of Nantes

    Nantes

  • University Hospital of Nîmes - Caremeau

    Nîmes

  • Pitié-Salpêtrière Hospital

    Paris, 75651

  • University Hospital of Poitiers

    Poitiers, 86021

  • University Hospital of Rennes

    Rennes, 35033

  • University Hospital of Rouen

    Rouen, 76031

  • University Hospital of Strasbourg

    Strasbourg, 67098

  • Chu Toulouse

    Toulouse, 31059

Other trials in France

About this study

Official title: Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial

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

Read the detailed description

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)
  1. 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.
  2. 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.

Being tested
PR Oxycodone, Levodopa, Oxycodone Placebo, Levodopa placebo
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PR OxycodoneDrug

    Also called PR Oxycontin

    PR Oxycodone

  • LevodopaDrug

    Also called Modopar

    Levodopa

  • Oxycodone PlaceboDrug

    Placebo of PR Oxycodone

  • Levodopa placeboDrug

Study groups in NCT02601586
Study groupRoleWhat they receive
PR oxycodoneExperimentalA 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:
Receives: Drug: PR Oxycodone; Drug: Levodopa placebo
levodopaActive comparatorA 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:
Receives: Drug: Levodopa; Drug: Oxycodone Placebo
PlaceboPlacebo comparatorA 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:
Receives: Drug: Oxycodone Placebo; Drug: Levodopa placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average pain intensity

    Change in average pain rated on visual analog scale (VAS) intensity between baseline and after 8 weeks

    Measured: 8 weeks

Secondary outcomes (13)

  1. Maximal pain intensity

    Change of maximal pain intensity over the preceding week rated on the VAS

    Measured: 8 weeks

  2. 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)

    Measured: 8 weeks

  3. Neuropathic Pain Symptoms Inventory (NPSI)

    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

    Measured: 8 weeks

  4. McGill pain questionnaire (SFMPQ)

    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

    Measured: 8 weeks

  5. 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)

    Measured: 8 weeks

  6. Apathy: the Lille Apathy Rating Scale (LARS)

    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

    Measured: 8 weeks

  7. Fatigue : the Parkinson fatigue scale

    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

    Measured: 8 weeks

  8. Sleep : the Pittsburgh sleep quality index

    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

    Measured: 8 weeks

  9. 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)

    Measured: 8 weeks

  10. 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)

    Measured: 8 weeks

  11. Acetaminophen consumption reported in diary

    number of pills or capsules reported in patients diary

    Measured: 8 weeks

  12. Adverse events

    Adverse events, evaluated with an open-ended questionnaire

    Measured: Day 5, Day 10, Day 15, Day 43, Day 71, Day 79

  13. 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.

    Measured: Day 0 /Day 71(Day 71= 8 weeks of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2015 (estimated)
  2. Study startSep 2016
  3. Primary completionNov 2020
  4. Study completionNov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02601586
Sponsor's protocol ID
14 7440 01
Acronym
OXYDOPA
Status last verified
Apr 2026
First submitted
17 Aug 2015
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38850081

  • 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.

    PubMed 35148289

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PR Oxycodone and Levodopa in people with Parkinson Disease, run by University Hospital, Toulouse at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average pain intensity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02601586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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