Post Stroke Spasticity Clinical Trial
— RelaxOfficial title:
Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
Verified date | November 2020 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Ipsen Facility | Hoofddorp |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Netherlands,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03459066 -
Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.
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