Skip to main content
OpenTrials
Completed

NCT Number: NCT04948684

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Atypical Parkinsonism Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Dystonia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avicenne Hospital

Bobigny, Seine-Saint-Denis, 93009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients

    Time frame: 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

Secondary outcomes

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

    Time frame: 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

Other outcomes

  1. Comparison of the patients' age between PD and AP groups

    Time frame: Baseline

    Age in years of patients from PD and AP groups

  2. Comparison of the sex-ratio between PD and AP groups

    Time frame: Screening

    Percentage of female (%) in PD and AP groups

  3. Comparison of the patients' duration of disease between PD and AP groups

    Time frame: Baseline

    Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups

  4. Comparison of the patients' severity of the disease between PD and AP groups

    Time frame: 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)

  5. Comparison of the patients' daily need in levodopa between PD and AP groups

    Time frame: Baseline

    Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups

  6. Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups

    Time frame: Baseline

    Percentage of patients treated with apomorphine (%) in PD and AP groups

  7. Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups

    Time frame: Baseline

    Percentage of patients treated with deep brain stimulation (%) in PD and AP groups

  8. Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia

    Time frame: Baseline

    Age in years

  9. Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia

    Time frame: Baseline

    Percentage of patients treated with deep brain stimulation (%) in both groups

  10. Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia

    Time frame: Baseline

    Percentage of patients treated with apomorphine (%) in both groups

  11. Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia

    Time frame: Baseline

    Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups

  12. Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia

    Time frame: 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)

  13. Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia

    Time frame: Baseline

    Duration of the disease (years since diagnosis of AP or PD) of patients

  14. Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia

    Time frame: Baseline

    Percentage of female (%)

  15. Comparison of the dystonia's characteristics between PD and AP groups : muscle affected

    Time frame: Day 0

    Muscle affected by dystonia (described with International Anatomical Terminology)

  16. Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia

    Time frame: Day 0

    Duration of the dystonia (years since first report of the dystonia)

  17. Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose

    Time frame: Day 0

    Dose of BoNT used (in mL)

  18. Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT

    Time frame: Day 0

    Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)

  19. Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection

    Time frame: Day 0

    Site of injection (described with International Anatomical Terminology)

  20. Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections

    Time frame: Day 0

    Number of injection performed during injection appointment

  21. Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance

    Time frame: Day 0

    Usage of ultrasound or electromyography to guide BoNT injection

Sponsors and collaborators

Lead sponsor

Hospital Avicenne

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.