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NCT Number: NCT07702266

Primary Parkinsonian Pain: Clinical Association and Phenotype

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • French-speaking.
  • Diagnosis of Parkinson's disease confirmed by a neurologist.

Exclusion criteria

  • Atypical parkinsonian syndrome.
  • Patients under legal protection (guardianship, curatorship, or legal safeguard measures).

Treatment and study plan

Online self-administered questionnaire

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Presence of anosmia

    Time frame: at day 0

    Self-reported olfactory dysfunction

  2. Presence of constipation

    Time frame: at day 0

    Self-reported constipation dysfunction

  3. Presence of impulsive control disorders according the QUIP-Anytime During PD-Short (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease)

    Time frame: at day 0

    This self-questionnaire is completed by the patient during the inclusion visit

  4. Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)

    Time frame: at day 0

    This self-questionnaire is completed by the patient during the inclusion visit

  5. Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)

    Time frame: at day 0

    This self-questionnaire is completed by the patient during the inclusion visit

  6. Pain intensity according an EVA scale

    Time frame: at day 0

    patients will evaluate their pain with an EVA scale at inclusion visit

  7. Presence of comorbidities

    Time frame: at day 0

    Patients will report if they had comorbidities such as diabete or osteoarticular disorders.

  8. presence of migraines

    Time frame: at day 0

    patient will report if he had migraines

  9. Current antiparkinsonian and analgesic treatments

    Time frame: at day 0

    Patient will report his current antiparkinsonian and analgesic treatments

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Lise Laclautre

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: PHENOPAIN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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