Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism

NCT04948684 | Completed

• 1 other identifier: CLEA-2021-167
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Atypical Parkinsonism; Dystonia

Keywords

Botulinum toxinum; Dystonia; Parkinson Disease; Atypical Parkinsonism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients

  Up to twelve months

Other Outcomes (21)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Diagnosed Parkinson's disease or Atypical Parkinsonism
• Age \> 18 years
• Reported dystonia
• At least 1 injection with Botulinum toxin realized

You may not qualify if:

• Refusal to participate in the study

Sponsors & Collaborators

• Hospital Avicenne: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Avicenne Hospital

Bobigny, Seine-Saint-Denis, 93009, France

Location

Related Publications (9)

• 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.

  PMID: 26559824 BACKGROUND

• 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.

  PMID: 28639368 BACKGROUND

• 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.

  PMID: 17131231 BACKGROUND

• 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.

  PMID: 31443953 BACKGROUND

• 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.

  PMID: 25407133 BACKGROUND

• 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.

  PMID: 7651452 BACKGROUND

• 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.

  PMID: 8201355 BACKGROUND

• 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.

  PMID: 29102441 BACKGROUND

• 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.

  PMID: 35854137 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand Degos, MD,PhD

  Hospital Avicenne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: interne

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: July 2, 2021
• Study Start: September 1, 2017
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)