Parkinson s DiseasePHENOPAINNCT07702266
Primary Parkinsonian Pain: Clinical Association and Phenotype
An observational study of Parkinson s Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Among the different types of pain observed in Parkinson's disease, primary parkinsonian pain (PPP) is the most severe, the most difficult to treat, but also the least well characterized and the hardest to describe, not only by patients but also by neurologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson s Disease
- What is being tested?
- Online self-administered questionnaire
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be contacted through the France Parkinson Association. If interested in the study, they will be able to access the online questionnaire hosted on the REDCap platform via a QR code or a web link.
Who may be able to join
- Age ≥ 18 years.
- French-speaking.
- Diagnosis of Parkinson's disease confirmed by a neurologist.
Who cannot join
- Atypical parkinsonian syndrome.
- Patients under legal protection (guardianship, curatorship, or legal safeguard measures).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lise Laclautre contact
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
About this study
Among the different types of pain observed in Parkinson's disease, primary parkinsonian pain (PPP) is the most severe, the most difficult to treat, but also the least well characterized and the hardest to describe, not only by patients but also by neurologists. Consequently, PPP remains difficult to identify, even for clinicians with expertise in Parkinson's disease.
Nevertheless, patients with Parkinson's disease who experience PPP appear to exhibit certain demographic and clinical characteristics that may help distinguish them from other patients, including a poorer motor response to levodopa, a stronger association with sleep disturbances, and cognitive and behavioral features such as impulse control disorders (ICDs). PPP may therefore be associated with a specific disease phenotype supported by distinct pathophysiological mechanisms.
Read more
Recently, a disease progression model proposed the existence of a "Brain-First" subtype (characterized by disease onset in the brainstem) and a "Body-First" subtype (characterized by disease onset in the gastrointestinal system). Several clinical markers appear to distinguish these subtypes, notably the presence of REM sleep behavior disorder (RBD), which has been associated with the Body-First phenotype.
The association between PPP and RBD, as well as between PPP and the Body-First subtype, has never been investigated. We hypothesize that PPP may be associated with several clinical markers of the Body-First phenotype. Identifying such associations could facilitate the routine clinical diagnosis of PPP and, consequently, improve its management, which remains inadequate at present.
The primary objective is to assess the proportion of patients with primary parkinsonian pain according to the presence of probable RBD in Parkinson's disease.
This prospective, cross-sectional, non-interventional category 3 study (RIPH 3) will be conducted in 300 patients. Patients contacted through the France Parkinson Association and interested in participating in the study will be able to access the online questionnaire via a QR code or a web link. Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.
- Conditions
- Parkinson s Disease
- Being tested
- Online self-administered questionnaire
- Keywords
- Parkinson's disease, RBD, pain
- 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.
Online self-administered questionnaireOther
Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.
| Study group | Role | What they receive |
|---|---|---|
| Parkinsonian patients | Patients with a diagnosis of Parkinson's disease confirmed by a neurologist Receives: Other: Online self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of primary parkinsonian pain according to the 3PDQ questionnaire
This self-questionnaire is completed by the patient during the inclusion visit
Measured: at day 0
Probable REM sleep behavior disorder (RBD), as identified using the RBD-1Q (REM Sleep Behavior Disorder Single-Question Screen).
This self-questionnaire is completed by the patient during the inclusion visit
Measured: at day 0
Secondary outcomes (9)
Presence of anosmia
Self-reported olfactory dysfunction
Measured: at day 0
Presence of constipation
Self-reported constipation dysfunction
Measured: at day 0
Presence of impulsive control disorders
Self reported impulse control disorders
Measured: at day 0
Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)
This self-questionnaire is completed by the patient during the inclusion visit
Measured: at day 0
Presence of RBD according the RBD SQ (RBD-Screening Questionnaire)
This self-questionnaire is completed by the patient during the inclusion visit
Measured: at day 0
Pain intensity according an EVA scale
patients will evaluate their pain with an EVA scale at inclusion visit
Measured: at day 0
Presence of comorbidities
Patients will report if they had comorbidities such as diabete or osteoarticular disorders.
Measured: at day 0
presence of migraines
patient will report if he had migraines
Measured: at day 0
Current antiparkinsonian and analgesic treatments
Patient will report his current antiparkinsonian and analgesic treatments
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startSep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson s DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702266
- Sponsor's protocol ID
- RNI 2026 MARQUES
- Other IDs
- 2026-A01046-45
- Acronym
- PHENOPAIN
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Parkinsonian Pain: Clinical Association and Phenotype
- ClinicalTrials.gov ID
- NCT07702266
- Acronym / sponsor ID
- PHENOPAIN / RNI 2026 MARQUES
- Conditions
- Parkinson s Disease
- Keywords
- Parkinson's disease, RBD, pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 14 Jul 2026 (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.
Among the different types of pain observed in Parkinson's disease, primary parkinsonian pain (PPP) is the most severe, the most difficult to treat, but also the least well characterized and the hardest to describe, not only by patients but also by neurologists. Consequently, PPP remains difficult to identify, even for clinicians with expertise in Parkinson's disease.
Nevertheless, patients with Parkinson's disease who experience PPP appear to exhibit certain demographic and clinical characteristics that may help distinguish them from other patients, including a poorer motor response to levodopa, a stronger association with sleep disturbances, and cognitive and behavioral features such as impulse control disorders (ICDs). PPP may therefore be associated with a specific disease phenotype supported by distinct pathophysiological mechanisms.
Recently, a disease progression model proposed the existence of a "Brain-First" subtype (characterized by disease onset in the brainstem) and a "Body-First" subtype (characterized by disease onset in the gastrointestinal system). Several clinical markers appear to distinguish these subtypes, notably the presence of REM sleep behavior disorder (RBD), which has been associated with the Body-First phenotype.
The association between PPP and RBD, as well as between PPP and the Body-First subtype, has never been investigated. We hypothesize that PPP may be associated with several clinical markers of the Body-First phenotype. Identifying such associations could facilitate the routine clinical diagnosis of PPP and, consequently, improve its management, which remains inadequate at present.
The primary objective is to assess the proportion of patients with primary parkinsonian pain according to the presence of probable RBD in Parkinson's disease.
This prospective, cross-sectional, non-interventional category 3 study (RIPH 3) will be conducted in 300 patients. Patients contacted through the France Parkinson Association and interested in participating in the study will be able to access the online questionnaire via a QR code or a web link. Completion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinsonian patients | – | Other: Online self-administered questionnairePatients with a diagnosis of Parkinson's disease confirmed by a neurologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be contacted through the France Parkinson Association. If interested in the study, they will be able to access the online questionnaire hosted on the REDCap platform via a QR code or a web link.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- French-speaking.
- Diagnosis of Parkinson's disease confirmed by a neurologist.
Key exclusion criteria (2 listed)
- Atypical parkinsonian syndrome.
- Patients under legal protection (guardianship, curatorship, or legal safeguard measures).
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 |
|---|---|---|
| Online self-administered questionnaireCompletion of the questionnaire is expected to take no more than 15 minutes. This self-administered questionnaire will include collection of general data (age, sex, disease duration, initial motor symptoms, side of symptom onset predominance, and comorbidities), assessments of pain, migraine, sleep, constipation, olfaction, anxiety and depression and impulse control disorders. | Other | Parkinsonian patients |
Primary outcome
Presence of primary parkinsonian pain according to the 3PDQ questionnaire
Time frame: at day 0
This self-questionnaire is completed by the patient during the inclusion visit
Probable REM sleep behavior disorder (RBD), as identified using the RBD-1Q (REM Sleep Behavior Disorder Single-Question Screen).
Time frame: at day 0
This self-questionnaire is completed by the patient during the inclusion visit
9 secondary outcomes
Presence of anosmia
Time frame: at day 0
Presence of constipation
Time frame: at day 0
Presence of impulsive control disorders
Time frame: at day 0
Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)
Time frame: at day 0
Presence of RBD according the RBD SQ (RBD-Screening Questionnaire)
Time frame: at day 0
Pain intensity according an EVA scale
Time frame: at day 0
Presence of comorbidities
Time frame: at day 0
presence of migraines
Time frame: at day 0
Current antiparkinsonian and analgesic treatments
Time frame: at day 0
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lise Laclautre contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson s Disease, run by University Hospital, Clermont-Ferrand at 1 site 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 3 inclusion and 2 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of primary parkinsonian pain according to the 3PDQ questionnaire (time frame: at day 0). The study lists 2 primary outcomes in all. 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 16 Oct 2026.