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NCT06386848 Clinical Trial

Strategy to Adapt Botulinum Toxin Doses in Dystonia

Dystonia Clinical Trial

Official title:
Strategy to Adapt Botulinum Toxin Doses in Dystonia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06386848
Other study ID # 2023PI187
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date June 1, 2024

Study information
Verified date January 2024
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended. We we ll study the increase of the dose injected over the time, the side effects... The hypothesis is that we inject smaller doses than we could regarding the recommandations

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients over 18 years old followed for dystonia and treated with botulinum toxin Exclusion Criteria: - first dose of botulinum toxin not available

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum toxin
Botulinum toxin doses injected in dystonia

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary First dose of botulinum toxin injected, U dose injected in U 30 years
Secondary Effective dose of botulinum toxin dose injected in U 30 years
Secondary Side effects diplopia, ptosis and others 30 years
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