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

November 25, 2020 updated by: Ipsen
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

451

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Hoofddorp, Netherlands, 2132LS
        • Ipsen Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients selected from the database claimed within the code 313 will be included in the descriptive analyses.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean time to next injection per brand
Time Frame: From baseline up to end of data collection (January 2012 up to December 2016)
From baseline up to end of data collection (January 2012 up to December 2016)
Median time to next injection per brand
Time Frame: From baseline up to end of data collection (January 2012 up to December 2016)
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
Time Frame: From baseline up to end of data collection (January 2012 up to December 2016)
From baseline up to end of data collection (January 2012 up to December 2016)

Secondary Outcome Measures

Outcome Measure
Time Frame
Average cost per year per brand per patient
Time Frame: From baseline up to end of data collection (January 2012 up to December 2016)
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
Time Frame: From baseline up to end of data collection (January 2012 up to December 2016)
From baseline up to end of data collection (January 2012 up to December 2016)
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)
From baseline up to end of data collection (January 2012 up to December 2016)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2020

Primary Completion (Actual)

September 18, 2020

Study Completion (Actual)

September 18, 2020

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-52120-450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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