- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Lise Laclautre
- Número de telefone: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Estude backup de contato
- Nome: Lise Laclautre
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Locais de estudo
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Clermont-Ferrand, França
- CHU clermont-ferrand
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Investigador principal:
- Ana MARQUES
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Contato:
- Lise Laclautre
- Número de telefone: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Contato:
- Lise Laclautre
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Parkinsonian patients
Patients with a diagnosis of Parkinson's disease confirmed by a neurologist
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Presence of primary parkinsonian pain according to the 3PDQ questionnaire
Prazo: 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).
Prazo: at day 0
|
This self-questionnaire is completed by the patient during the inclusion visit
|
at day 0
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Presence of anosmia
Prazo: at day 0
|
Self-reported olfactory dysfunction
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at day 0
|
|
Presence of constipation
Prazo: at day 0
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Self-reported constipation dysfunction
|
at day 0
|
|
Presence of impulsive control disorders according the QUIP-Anytime During PD-Short (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease)
Prazo: at day 0
|
This self-questionnaire is completed by the patient during the inclusion visit
|
at day 0
|
|
Presence of Anxiety and/or depression according the HADs (Hospital Anxiety and Depression scale)
Prazo: at day 0
|
This self-questionnaire is completed by the patient during the inclusion visit
|
at day 0
|
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Prsence of RBD according the RBD SQ (RBD-Screening Questionnaire)
Prazo: at day 0
|
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
Prazo: at day 0
|
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
Prazo: at day 0
|
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
Prazo: at day 0
|
patient will report if he had migraines
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at day 0
|
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Current antiparkinsonian and analgesic treatments
Prazo: at day 0
|
Patient will report his current antiparkinsonian and analgesic treatments
|
at day 0
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sinucleinopatias
- Manifestações Neurológicas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Neurodegenerativas
- Distúrbios do Movimento
- Distúrbios parkinsonianos
- Doenças dos Gânglios da Base
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor
- Doença de Parkinson
Outros números de identificação do estudo
- RNI 2026 MARQUES
- 2026-A01046-45 (Identificador de registro: n° IDRCB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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