Skip to main content
OpenTrials
Completed

NCT Number: NCT04649632

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Stroke Spasticity

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Facility

Hoofddorp, 2132LS, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean time to next injection per brand

    Time frame: From baseline up to end of data collection (January 2012 up to December 2016)

  2. Median time to next injection per brand

    Time frame: From baseline up to end of data collection (January 2012 up to December 2016)

  3. Dosing of botulinum toxin-A in daily practice in relation to time to next injection

    Time frame: From baseline up to end of data collection (January 2012 up to December 2016)

Secondary outcomes

  1. Average cost per year per brand per patient

    Time frame: From baseline up to end of data collection (January 2012 up to December 2016)

  2. Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments

    Time frame: From baseline up to end of data collection (January 2012 up to December 2016)

  3. Time interval between 2 injections of the same brand

    Time frame: From baseline up to end of data collection (January 2012 up to December 2016)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Acronym: Relax

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.