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

Post Stroke Spasticity Clinical Trial

— Relax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649632
• Other study ID #: CLIN-52120-450
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Muscle Spasticity
• Post Stroke Spasticity

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)