Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
24 juni 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Studietype
Observationeel
Inschrijving (Werkelijk)
63
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, Frankrijk, 93009
- Avicenne Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Comparison of the patients' age between PD and AP groups
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Baseline
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Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Bertrand Degos, MD,PhD, Hospital AVICENNE
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2017
Primaire voltooiing (Werkelijk)
11 februari 2021
Studie voltooiing (Werkelijk)
11 februari 2021
Studieregistratiedata
Eerst ingediend
6 juni 2021
Eerst ingediend dat voldeed aan de QC-criteria
24 juni 2021
Eerst geplaatst (Werkelijk)
2 juli 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juli 2021
Laatste update ingediend die voldeed aan QC-criteria
24 juni 2021
Laatst geverifieerd
1 juni 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CLEA-2021-167
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .