Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
24. juni 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
63
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, Frankrike, 93009
- Avicenne Hospital
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
Tidsramme: 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
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Up to twelve months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of the patients' age between PD and AP groups
Tidsramme: Baseline
|
Age in years of patients from PD and AP groups
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Baseline
|
|
Comparison of the sex-ratio between PD and AP groups
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Percentage of female (%)
|
Baseline
|
|
Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
Tidsramme: Day 0
|
Muscle affected by dystonia (described with International Anatomical Terminology)
|
Day 0
|
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Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
Tidsramme: 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
Tidsramme: Day 0
|
Dose of BoNT used (in mL)
|
Day 0
|
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT
Tidsramme: Day 0
|
Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)
|
Day 0
|
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection
Tidsramme: Day 0
|
Site of injection (described with International Anatomical Terminology)
|
Day 0
|
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections
Tidsramme: 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
Tidsramme: Day 0
|
Usage of ultrasound or electromyography to guide BoNT injection
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Day 0
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Bertrand Degos, MD,PhD, Hospital AVICENNE
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2017
Primær fullføring (Faktiske)
11. februar 2021
Studiet fullført (Faktiske)
11. februar 2021
Datoer for studieregistrering
Først innsendt
6. juni 2021
Først innsendt som oppfylte QC-kriteriene
24. juni 2021
Først lagt ut (Faktiske)
2. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2021
Sist bekreftet
1. juni 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLEA-2021-167
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .