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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04649632
Other study ID # CLIN-52120-450
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 29, 2020
Est. completion date September 18, 2020

Study information

Verified date November 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.


Recruitment information / eligibility

Status Completed
Enrollment 451
Est. completion date September 18, 2020
Est. primary completion date September 18, 2020
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility Inclusion Criteria: - A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox Exclusion Criteria: - A patient will be excluded if he has been only treated with Xeomin

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Ipsen Facility Hoofddorp

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean time to next injection per brand From baseline up to end of data collection (January 2012 up to December 2016)
Primary Median time to next injection per brand From baseline up to end of data collection (January 2012 up to December 2016)
Primary Dosing of botulinum toxin-A in daily practice in relation to time to next injection From baseline up to end of data collection (January 2012 up to December 2016)
Secondary Average cost per year per brand per patient From baseline up to end of data collection (January 2012 up to December 2016)
Secondary Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments From baseline up to end of data collection (January 2012 up to December 2016)
Secondary Time interval between 2 injections of the same brand From baseline up to end of data collection (January 2012 up to December 2016)
See also
  Status Clinical Trial Phase
Completed NCT03459066 - Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.