NCT06386848

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 26, 2024

Status Verified

January 1, 2024

Enrollment Period

Same day

First QC Date

January 18, 2024

Last Update Submit

April 24, 2024

Conditions

Dystonia

Outcome Measures

Primary Outcomes (1)

  • First dose of botulinum toxin injected, U

    dose injected in U

    30 years

Secondary Outcomes (2)

  • Effective dose of botulinum toxin

    30 years

  • Side effects

    30 years

Interventions

Botulinum toxinDRUG

Botulinum toxin doses injected in dystonia

Also known as: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years diagnosed with dystonia

You may qualify if:

  • patients over 18 years old followed for dystonia and treated with botulinum toxin

You may not qualify if:

  • first dose of botulinum toxin not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dystonia

Interventions

Botulinum ToxinsBotulinum Toxins, Type AabobotulinumtoxinAincobotulinumtoxinA

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Kryllof-Frismand Solène

Study Record Dates

First Submitted

January 18, 2024

First Posted

April 26, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

April 26, 2024

Record last verified: 2024-01