Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
24 de junio de 2021 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
63
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Seine-Saint-Denis
-
Bobigny, Seine-Saint-Denis, Francia, 93009
- Avicenne Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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
|
|
Patients with atypical Parkinsonism or Parkinson's disease and no dystonia
Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
Periodo de tiempo: Up to twelve months
|
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
|
Up to twelve months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Periodo de tiempo: Up to twelve months
|
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
|
Up to twelve months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comparison of the patients' age between PD and AP groups
Periodo de tiempo: Baseline
|
Age in years of patients from PD and AP groups
|
Baseline
|
|
Comparison of the sex-ratio between PD and AP groups
Periodo de tiempo: Screening
|
Percentage of female (%) in PD and AP groups
|
Screening
|
|
Comparison of the patients' duration of disease between PD and AP groups
Periodo de tiempo: Baseline
|
Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups
|
Baseline
|
|
Comparison of the patients' severity of the disease between PD and AP groups
Periodo de tiempo: Baseline
|
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)
|
Baseline
|
|
Comparison of the patients' daily need in levodopa between PD and AP groups
Periodo de tiempo: Baseline
|
Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups
|
Baseline
|
|
Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups
Periodo de tiempo: Baseline
|
Percentage of patients treated with apomorphine (%) in PD and AP groups
|
Baseline
|
|
Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups
Periodo de tiempo: Baseline
|
Percentage of patients treated with deep brain stimulation (%) in PD and AP groups
|
Baseline
|
|
Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
Age in years
|
Baseline
|
|
Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
Percentage of patients treated with deep brain stimulation (%) in both groups
|
Baseline
|
|
Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
Percentage of patients treated with apomorphine (%) in both groups
|
Baseline
|
|
Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups
|
Baseline
|
|
Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
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)
|
Baseline
|
|
Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
Duration of the disease (years since diagnosis of AP or PD) of patients
|
Baseline
|
|
Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia
Periodo de tiempo: Baseline
|
Percentage of female (%)
|
Baseline
|
|
Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
Periodo de tiempo: Day 0
|
Muscle affected by dystonia (described with International Anatomical Terminology)
|
Day 0
|
|
Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
Periodo de tiempo: Day 0
|
Duration of the dystonia (years since first report of the dystonia)
|
Day 0
|
|
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose
Periodo de tiempo: Day 0
|
Dose of BoNT used (in mL)
|
Day 0
|
|
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT
Periodo de tiempo: Day 0
|
Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)
|
Day 0
|
|
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection
Periodo de tiempo: Day 0
|
Site of injection (described with International Anatomical Terminology)
|
Day 0
|
|
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections
Periodo de tiempo: Day 0
|
Number of injection performed during injection appointment
|
Day 0
|
|
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance
Periodo de tiempo: Day 0
|
Usage of ultrasound or electromyography to guide BoNT injection
|
Day 0
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bertrand Degos, MD,PhD, Hospital AVICENNE
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2017
Finalización primaria (Actual)
11 de febrero de 2021
Finalización del estudio (Actual)
11 de febrero de 2021
Fechas de registro del estudio
Enviado por primera vez
6 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2021
Publicado por primera vez (Actual)
2 de julio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
24 de junio de 2021
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Discinesias
- Enfermedad de Parkinson
- Distonía
- Trastornos distónicos
- Trastornos Parkinsonianos
Otros números de identificación del estudio
- CLEA-2021-167
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .