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

Completed

• Conditions: Parkinson Disease; Dystonia; Atypical Parkinsonism

• Registration Number: NCT04948684
• Lead Sponsor: Hospital Avicenne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2021-02-11
• Study Completion: 2021-02-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients	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 Outcome Measures

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

Trial Locations

Locations (1)

Avicenne Hospital; 🇫🇷 Bobigny, Seine-Saint-Denis, France