Parkinson DiseasePAINPARKNCT07127146
Opioidergic and Noradrenergic Systems in Central Parkisonian Pain
A study testing PET-MRI exam with administration of [11C]Carfentanil and PET-MRI exam with administration of [11C]Yohimbine in people with Parkinson Disease, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
The goal of this study is to evaluate the differences in functional physiopathology of the opioid and noradrenergic systems between Parkinson's patients with central pain and Parkinson's patients without central pain. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PET-MRI exam with administration of [11C]Carfentanil and PET-MRI exam with administration of [11C]Yohimbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Oct 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease based on MDS-UPDRS criteria (Group 1 and 2)
- Dopaminergic therapy stable with stable dose for at least 4 weeks prior to J0
- Affiliate to a social security or similar system
- Having given written consent to participate in the study, free and informed.
- Having chronic pain more than 3 month (Group 1)
- Without chronic pain (Groupe 2 and 3)
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- Having central pain using specific algorithm (Marques et al., 2019)
- Having pain intensity at least 4 on VAS (Visual Analogue Scale) during the last month (Group 1)
- Having pain intensity lower than 3 on VAS (Visual Analogue Scale) during the last month (Group 2 and 3)
Who cannot join
- Having atypical Parkinson's disease (Group 1 and 2)
- Parkinson's disease with disabling dyskinesia and/or severe tremor (Group 1 and 2)
- Any contraindications to having a brain MRI or PET scan (e.g., pacemaker, metal foreign body, claustrophobia, deep brain stimulation or apomorphin pump unable to be turn off)
- History of head trauma with loss of consciousness lasting more than 30 minutes
- Not agreeing to be informed in the event of incidental discovery of an abnormality on MRI or during neuropsychological assessment
- Presence of cognitive dysfunction (defined as MoCA score < 24)
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- Severe depression (BDI > 29)
- unable to stop the opioid treatment the week before the imaging exam ( e.g., Antarène codéine, Claradol codéine, Codoliprane, Dafalgan codéine, Euphon, Klipal, Lindilane, Néo-codion, Paderyl, Prontalgine, Pulmoserum, Tussipax ; Opium : Izalgi, Lamaline, Colchimax, Dropizal ; Morphine : Actiskenan, Moscontin, Oramorph, Sevredol, Skenan ; Buprénorphine : Bupensan, Buvidal, Orobupre, Sixmo, Suboxone, Subutex, Temgesic, Zubsolv ; Dihydrocodéine : Dicodin ; Hydromorphone : Sophidone ; Nalbuphine : Nalpain ; Fentanyl : Abstral, Actiq, Breakyl, Durogesic, Effentora, Instanyl, Matrifen, Pecfent, Recivit ; Méthadone : Methadone AP-HP, Zorvon ; Oxycodone : Oxsynia, Oxycontin, Oxynorm, Oxynormoro ; Tramadol : Biodalgic, Contramal, Ixprim, Monoalgic, Monocrixo, Orozamudol, Skudexum, Topalgic, Zaldiar, Zamudol, Zumalgic)
- unable to stop any treatment
- Treated with level 1 analgesics (NSAIDs, acetaminophen) or coanalgesics (antidepressants, antiepileptics) unless treatment has been stable for at least 4 weeks prior to the study and does not interfere with the noradrenergic system (list above).
- Presenting or having presented a dependence on any addictive substance according to DSM-IV-TR criteria, with the exception of tobacco.
- Having used recreational drugs interfering with the opioid and noradrenergic systems (cannabis, CBD, opiates, MDMA, ecstasy) in the last 3 months or chronic use
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Under psychiatric care
- Admitted to a health or social institution for purposes other than research
- Under legal protection (guardianship, curatorship)
- Participant in another interventional study with an exclusion period still in progress at pre-inclusion
- Having exceeded the annual amount of compensation authorized for participation in research protocols
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Hôpital Neurologique Pierre Wertheimer
Bron, 69677
Mathilde Millot-Troesch, CRA, 04 72 35 70 58, mathilde.millot-troesch@chu-lyon.fr
Stéphane THOBOIS, MD
CHU de Clermont-Ferrand Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Anna MARQUES, PHD, 04 73 75 16 00, Ar_marques@chu-clermontferrand.fr
Anna MARQUES, PHD
CHU de Toulouse - Hôpital Purpan
Toulouse, 31059
Christine Brefel-Courbon, MD, 05 61 77 25 35, christine.brefel-courbon@univ-tlse3.fr
Christine Brefel-Courbon, MD
About this study
Official title: Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain
The goal of this study is to evaluate the differences in functional physiopathology of the opioid and noradrenergic systems between Parkinson's patients with central pain and Parkinson's patients without central pain. Using PET-MRI data, investigators aim to observe opioids receptors availability using [11C]Carfentanil (µ opioid receptor agonist) and altered α2-AR density with [11C]Yohimbine (adrenergic α2 receptor antagonist).
- Conditions
- Parkinson Disease
- Being tested
- PET-MRI exam with administration of [11C]Carfentanil, PET-MRI exam with administration of [11C]Yohimbine
- Keywords
- Pain, Parkinson's disease, Noradrenergic system, Opioidergic system, PET-MRI
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRI exam with administration of [11C]CarfentanilOther
Recording of functional neuroimaging data will begin immediately after intravenous injection of [11C]Carfentanil and will last for 51 minutes in a resting state. The dose will be 250 MBq/kg +-10 %.
PET-MRI exam with administration of [11C]YohimbineOther
Recording of functional neuroimaging data will begin immediately after intravenous injection of [11C]Yohimbine and will last for 70 minutes in a resting state. The dose will be 370 MBq/kg +- 10 %.
| Study group | Role | What they receive |
|---|---|---|
| PD-P (Parkinson's patient with pain) | Experimental | Parkinson's patients suffering from chronic and central pain and with a VAS score of at least 4 points.
They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine Receives: Other: PET-MRI exam with administration of [11C]Carfentanil; Other: PET-MRI exam with administration of [11C]Yohimbine |
| PD-NP (Parkinson's patient with no pain) | Experimental | Parkinson's patients without chronic and central pain and with a VASscore below 3 points They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine Receives: Other: PET-MRI exam with administration of [11C]Carfentanil; Other: PET-MRI exam with administration of [11C]Yohimbine |
| Healthy volunteers | Experimental | Healthy volunteers without chronic pain and with a VAS score below 3 points They will perform a PET MRI with the [11C]Carfentanil radiotracer Receives: Other: PET-MRI exam with administration of [11C]Carfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between non-displaceable binding potential of radiotracer in brain region involved in pain
Differences between binding potential (BPND )of [11C]Carfentanil on the µ-opioid receptor and [11C]Yohimbine on α2-AR in PD-P and PD-NP patients
Measured: At the time of PET-MRI scan at Day 75
Secondary outcomes (3)
Correlation between BPND of both tracer and pain intensity of parkinsonian patient
Correlation between BPND measured with the [11C]Carfentanil and the[11C]Yohimbine and the pain intensity of all PD patient measured with clinical scores
Measured: At the time of PET-MRI scan at Day 75
Pain matrix area
Compare the resting functional connectivity in the pain matrix area (insula, pre frontal cortex, thalamus) between groups of patients with and without pain.
Measured: At the time of PET-MRI scan at Day 75
ASL measure
Observation of the blood flow modification through ASL measure in the brain pain areas between PD-P and PD-NP patients
Measured: At the time of PET-MRI scan at Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned in 3 parallel groups without randomization : * group1 20 patients analyzable with Parkinson's disease suffering from central pain (PD-P) * Group 2 20 patients analyzable with Parkinson's disease without central pain (PD-NP) matched for sex and age. * Group 3 15 healthy volunteers analyzable (HC) matched for sex and age.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane THOBOIS, PHD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127146
- Sponsor's protocol ID
- 69HCL24_0721
- Acronym
- PAINPARK
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not definied yet
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain
- ClinicalTrials.gov ID
- NCT07127146
- Acronym / sponsor ID
- PAINPARK / 69HCL24_0721
- Conditions
- Parkinson Disease
- Keywords
- Pain, Parkinson's disease, Noradrenergic system, Opioidergic system, PET-MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the differences in functional physiopathology of the opioid and noradrenergic systems between Parkinson's patients with central pain and Parkinson's patients without central pain. Using PET-MRI data, investigators aim to observe opioids receptors availability using [11C]Carfentanil (µ opioid receptor agonist) and altered α2-AR density with [11C]Yohimbine (adrenergic α2 receptor antagonist).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned in 3 parallel groups without randomization : * group1 20 patients analyzable with Parkinson's disease suffering from central pain (PD-P) * Group 2 20 patients analyzable with Parkinson's disease without central pain (PD-NP) matched for sex and age. * Group 3 15 healthy volunteers analyzable (HC) matched for sex and age.
| Arm | Type | Receives |
|---|---|---|
| PD-P (Parkinson's patient with pain) | Experimental | Other: PET-MRI exam with administration of [11C]Carfentanil, Other: PET-MRI exam with administration of [11C]YohimbineParkinson's patients suffering from chronic and central pain and with a VAS score of at least 4 points. They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine |
| PD-NP (Parkinson's patient with no pain) | Experimental | Other: PET-MRI exam with administration of [11C]Carfentanil, Other: PET-MRI exam with administration of [11C]YohimbineParkinson's patients without chronic and central pain and with a VASscore below 3 points They will perform 2 different PET MRI with radiotracer , one using [11C]Carfentanil and the other one using [11C]Yohimbine |
| Healthy volunteers | Experimental | Other: PET-MRI exam with administration of [11C]CarfentanilHealthy volunteers without chronic pain and with a VAS score below 3 points They will perform a PET MRI with the [11C]Carfentanil radiotracer |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Parkinson's disease based on MDS-UPDRS criteria (Group 1 and 2)
- Dopaminergic therapy stable with stable dose for at least 4 weeks prior to J0
- Affiliate to a social security or similar system
- Having given written consent to participate in the study, free and informed.
- Having chronic pain more than 3 month (Group 1)
Key exclusion criteria (19 listed)
- Having atypical Parkinson's disease (Group 1 and 2)
- Parkinson's disease with disabling dyskinesia and/or severe tremor (Group 1 and 2)
- Any contraindications to having a brain MRI or PET scan (e.g., pacemaker, metal foreign body, claustrophobia, deep brain stimulation or apomorphin pump unable to be turn off)
- History of head trauma with loss of consciousness lasting more than 30 minutes
- Not agreeing to be informed in the event of incidental discovery of an abnormality on MRI or during neuropsychological assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRI exam with administration of [11C]CarfentanilRecording of functional neuroimaging data will begin immediately after intravenous injection of [11C]Carfentanil and will last for 51 minutes in a resting state. The dose will be 250 MBq/kg +-10 %. | Other | Healthy volunteers, PD-NP (Parkinson's patient with no pain), PD-P (Parkinson's patient with pain) |
| PET-MRI exam with administration of [11C]YohimbineRecording of functional neuroimaging data will begin immediately after intravenous injection of [11C]Yohimbine and will last for 70 minutes in a resting state. The dose will be 370 MBq/kg +- 10 %. | Other | PD-NP (Parkinson's patient with no pain), PD-P (Parkinson's patient with pain) |
Primary outcome
Difference between non-displaceable binding potential of radiotracer in brain region involved in pain
Time frame: At the time of PET-MRI scan at Day 75
Differences between binding potential (BPND )of [11C]Carfentanil on the µ-opioid receptor and [11C]Yohimbine on α2-AR in PD-P and PD-NP patients
3 secondary outcomes
Correlation between BPND of both tracer and pain intensity of parkinsonian patient
Time frame: At the time of PET-MRI scan at Day 75
Pain matrix area
Time frame: At the time of PET-MRI scan at Day 75
ASL measure
Time frame: At the time of PET-MRI scan at Day 75
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided. It is not definied yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane THOBOIS, PHD study director
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI exam with administration of [11C]Carfentanil and PET-MRI exam with administration of [11C]Yohimbine in people with Parkinson Disease, run by Hospices Civils de Lyon at 3 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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Millot-Troesch, CRA (04 72 35 70 58, mathilde.millot-troesch@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between non-displaceable binding potential of radiotracer in brain region involved in pain (time frame: At the time of PET-MRI scan at Day 75). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025.