NCT04948684|Completed
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Sponsor study identifier
observational
63
1 country
1
Study Start
September 1, 2017
Actual (reported)Primary Completion
February 11, 2021
Actual (reported)Study Completion
February 11, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 11, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2017
Actual (reported)February 11, 2021
Actual (reported)February 11, 2021
Actual (reported)June 6, 2021
Actual (reported)July 2, 2021
Actual (reported)Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
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
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Up to twelve months
Comparison of the patients' age between PD and AP groups
Baseline
Comparison of the sex-ratio between PD and AP groups
Screening
Comparison of the patients' duration of disease between PD and AP groups
Baseline
Patients with dystonia secondary to idiopathic Parkinson's disease or atypical parkinsonism and treated with BoNT
Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia
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.
Avicenne Hospital
Bobigny, Seine-Saint-Denis, 93009, France
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.
Bertrand Degos, MD,PhD
Hospital Avicenne
63 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2021
First Posted
July 2, 2021
Study Start
September 1, 2017
Actual (reported)Role of the Striatal Cholinergic System in the Pathophysiology of Dystonia
Abnormal Movements, Cerebellum and Sensorimotor : Oculomotor Study
Contact the study team to confirm eligibility.
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.
Primary Completion
February 11, 2021
Actual (reported)Study Completion
February 11, 2021
Actual (reported)Last Updated
July 2, 2021
Record last verified: 2021-06
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