Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
24 de junho de 2021 atualizado por: Arnaud Lapostolle, Hospital Avicenne
Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism: a Monocentric Cohort Study With Patient Reported Outcome
Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP).
Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia.
The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP.
The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
63
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, França, 93009
- Avicenne Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
All patients that have been evaluated in the Neurology department of Avicenne Hospital (academic medical center) between september 1st 2017 and february 11th 2021.
Data will be retrospectively collected within the medical records of those patients.
Descrição
Inclusion Criteria:
- Diagnosed Parkinson's disease or Atypical Parkinsonism
- Age > 18 years
- Reported dystonia
- At least 1 injection with Botulinum toxin realized
Exclusion Criteria:
- Refusal to participate in the study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Patients with dystonia secondary to atypical Parkinsonism or Parkinson's disease
Patients with dystonia secondary to idiopathic Parkinson's disease or atypical parkinsonism and treated with BoNT
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Patients with atypical Parkinsonism or Parkinson's disease and no dystonia
Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
Prazo: Up to twelve months
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Evaluation by the patient of the efficacy of the former injection on an improvement scale ranging from 0 to 100% (minimum value : 0, maximum value : 100, higher scores mean a better outcome) systematically made in routine care during follow up appointment
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Up to twelve months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Prazo: Up to twelve months
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Evaluation by the patient of the duration of the period during which symptoms were improved (in weeks) systematically made in routine care during follow up appointment
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Up to twelve months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Comparison of the patients' age between PD and AP groups
Prazo: Baseline
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Age in years of patients from PD and AP groups
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Baseline
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Comparison of the sex-ratio between PD and AP groups
Prazo: Screening
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Percentage of female (%) in PD and AP groups
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Screening
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Comparison of the patients' duration of disease between PD and AP groups
Prazo: Baseline
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Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups
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Baseline
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Comparison of the patients' severity of the disease between PD and AP groups
Prazo: Baseline
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Severity of the disease in both PD and AP groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease)
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Baseline
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Comparison of the patients' daily need in levodopa between PD and AP groups
Prazo: Baseline
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Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups
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Baseline
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Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups
Prazo: Baseline
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Percentage of patients treated with apomorphine (%) in PD and AP groups
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Baseline
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Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups
Prazo: Baseline
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Percentage of patients treated with deep brain stimulation (%) in PD and AP groups
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Baseline
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Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Age in years
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Baseline
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Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Percentage of patients treated with deep brain stimulation (%) in both groups
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Baseline
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Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Percentage of patients treated with apomorphine (%) in both groups
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Baseline
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Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups
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Baseline
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Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Severity of the disease in both groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease)
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Baseline
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Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Duration of the disease (years since diagnosis of AP or PD) of patients
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Baseline
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Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia
Prazo: Baseline
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Percentage of female (%)
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Baseline
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Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
Prazo: Day 0
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Muscle affected by dystonia (described with International Anatomical Terminology)
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Day 0
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Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
Prazo: Day 0
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Duration of the dystonia (years since first report of the dystonia)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose
Prazo: Day 0
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Dose of BoNT used (in mL)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT
Prazo: Day 0
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Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection
Prazo: Day 0
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Site of injection (described with International Anatomical Terminology)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections
Prazo: Day 0
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Number of injection performed during injection appointment
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance
Prazo: Day 0
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Usage of ultrasound or electromyography to guide BoNT injection
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Day 0
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bertrand Degos, MD,PhD, Hospital AVICENNE
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Dressler D. Botulinum toxin drugs: brief history and outlook. J Neural Transm (Vienna). 2016 Mar;123(3):277-9. doi: 10.1007/s00702-015-1478-1. Epub 2015 Nov 11.
- Jankovic J. Botulinum toxin: State of the art. Mov Disord. 2017 Aug;32(8):1131-1138. doi: 10.1002/mds.27072. Epub 2017 Jun 22.
- Tolosa E, Compta Y. Dystonia in Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII7-13. doi: 10.1007/s00415-006-7003-6.
- Marsili L, Bologna M, Kojovic M, Berardelli A, Espay AJ, Colosimo C. Dystonia in atypical parkinsonian disorders. Parkinsonism Relat Disord. 2019 Sep;66:25-33. doi: 10.1016/j.parkreldis.2019.07.030. Epub 2019 Jul 23.
- Mills R, Bahroo L, Pagan F. An update on the use of botulinum toxin therapy in Parkinson's disease. Curr Neurol Neurosci Rep. 2015 Jan;15(1):511. doi: 10.1007/s11910-014-0511-3.
- Pacchetti C, Albani G, Martignoni E, Godi L, Alfonsi E, Nappi G. "Off" painful dystonia in Parkinson's disease treated with botulinum toxin. Mov Disord. 1995 May;10(3):333-6. doi: 10.1002/mds.870100317.
- Giladi N, Meer J, Honigman S. The use of botulinum toxin to treat "striatal" toes. J Neurol Neurosurg Psychiatry. 1994 May;57(5):659. doi: 10.1136/jnnp.57.5.659. No abstract available.
- Rieu I, Degos B, Castelnovo G, Vial C, Durand E, Pereira B, Simonetta-Moreau M, Sangla S, Fluchere F, Guehl D, Burbaud P, Geny C, Gayraud D, Ory-Magne F, Bouhour F, Llinares E, Derost P, Marques A, Durif F. Incobotulinum toxin A in Parkinson's disease with foot dystonia: A double blind randomized trial. Parkinsonism Relat Disord. 2018 Jan;46:9-15. doi: 10.1016/j.parkreldis.2017.10.009. Epub 2017 Oct 19.
- Lapostolle A, Houot M, Mongin M, Degos B. Comparison of Botulinum neurotoxin efficiency in dystonia associated with Parkinson's disease and atypical parkinsonism: a retrospective study with a self-reported improvement scale. J Neurol. 2022 Nov;269(11):6021-6028. doi: 10.1007/s00415-022-11280-y. Epub 2022 Jul 19.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2017
Conclusão Primária (Real)
11 de fevereiro de 2021
Conclusão do estudo (Real)
11 de fevereiro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
6 de junho de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de junho de 2021
Primeira postagem (Real)
2 de julho de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de julho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de junho de 2021
Última verificação
1 de junho de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CLEA-2021-167
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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