- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07702266
Primary Parkinsonian Pain: Clinical Association and Phenotype (PHENOPAIN)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lise Laclautre
- Número de teléfono: +33473754963
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
Copia de seguridad de contactos de estudio
- Nombre: Lise Laclautre
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
Ubicaciones de estudio
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Clermont-Ferrand, Francia
- CHU clermont-ferrand
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Investigador principal:
- Ana MARQUES
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Contacto:
- Lise Laclautre
- Número de teléfono: +33473754963
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
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Contacto:
- Lise Laclautre
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Parkinsonian patients
Patients with a diagnosis of Parkinson's disease confirmed by a neurologist
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Presence of primary parkinsonian pain according to the 3PDQ questionnaire
Periodo de tiempo: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Probable REM sleep behavior disorder (RBD), as identified using the RBD-1Q (REM Sleep Behavior Disorder Single-Question Screen).
Periodo de tiempo: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Presence of anosmia
Periodo de tiempo: at day 0
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Self-reported olfactory dysfunction
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at day 0
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Presence of constipation
Periodo de tiempo: at day 0
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Self-reported constipation dysfunction
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at day 0
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Presence of impulsive control disorders according the QUIP-Anytime During PD-Short (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease)
Periodo de tiempo: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)
Periodo de tiempo: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)
Periodo de tiempo: at day 0
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This self-questionnaire is completed by the patient during the inclusion visit
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at day 0
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Pain intensity according an EVA scale
Periodo de tiempo: at day 0
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patients will evaluate their pain with an EVA scale at inclusion visit
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at day 0
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Presence of comorbidities
Periodo de tiempo: at day 0
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Patients will report if they had comorbidities such as diabete or osteoarticular disorders.
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at day 0
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presence of migraines
Periodo de tiempo: at day 0
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patient will report if he had migraines
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at day 0
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Current antiparkinsonian and analgesic treatments
Periodo de tiempo: at day 0
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Patient will report his current antiparkinsonian and analgesic treatments
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at day 0
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor
- Enfermedad de Parkinson
Otros números de identificación del estudio
- RNI 2026 MARQUES
- 2026-A01046-45 (Identificador de registro: n° IDRCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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