Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
Relax
1 other identifier
observational
451
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2020
CompletedFirst Submitted
Initial submission to the registry
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedDecember 2, 2020
November 1, 2020
5 months
November 12, 2020
November 25, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Mean time to next injection per brand
From baseline up to end of data collection (January 2012 up to December 2016)
Median time to next injection per brand
From baseline up to end of data collection (January 2012 up to December 2016)
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 Outcomes (3)
Average cost per year per brand per patient
From baseline up to end of data collection (January 2012 up to December 2016)
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)
Time interval between 2 injections of the same brand
From baseline up to end of data collection (January 2012 up to December 2016)
Eligibility Criteria
All patients selected from the database claimed within the code 313 will be included in the descriptive analyses.
You may qualify if:
- 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
You may not qualify if:
- A patient will be excluded if he has been only treated with Xeomin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (1)
Ipsen Facility
Hoofddorp, 2132LS, Netherlands
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2020
First Posted
December 2, 2020
Study Start
April 29, 2020
Primary Completion
September 18, 2020
Study Completion
September 18, 2020
Last Updated
December 2, 2020
Record last verified: 2020-11