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Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.

Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04649632
Acronym
Relax
Enrollment
451
Registered
2020-12-02
Start date
2020-04-29
Completion date
2020-09-18
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Stroke Spasticity

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.

Interventions

None listed

Sponsors

Ipsen
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean time to next injection per brandFrom baseline up to end of data collection (January 2012 up to December 2016)
Median time to next injection per brandFrom 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 injectionFrom baseline up to end of data collection (January 2012 up to December 2016)

Secondary

MeasureTime frame
Average cost per year per brand per patientFrom 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 treatmentsFrom baseline up to end of data collection (January 2012 up to December 2016)
Time interval between 2 injections of the same brandFrom baseline up to end of data collection (January 2012 up to December 2016)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026