Botulinum Toxin A Associated Costs in the Treatment of Upper Limb Spasticity Post Stroke (P_Dysport_CS)

January 4, 2019 updated by: Ipsen

Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal

This study aims to estimate the costs of botulinum toxin A utilization in standard practice for the treatment of upper limb spasticity post-stroke in Portugal.

It will consider the three most used locally available brands of botulinum toxin A which show similar efficacy and safety profiles thus making it relevant to understand if choosing between one or another brand can depend directly on economic factors.

The study will estimate direct and indirect drug-associated costs as determinant variables for the price of each drug and the standard drug dose used in clinical practice.

Study Overview

Status

Completed

Conditions

Detailed Description

A comparison will be performed between direct costs associated with each therapeutic strategy and cost analysis assuming that quality of life values may be different between patients treated with each treatment.

Study Type

Observational

Enrollment (Actual)

57

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

  • Portugal
      • Alcabideche, Portugal, 2649-506
        • Centro de Medicina de Reabilitação de Alcoitão
      • Faro, Portugal, 8000-386
        • C. H. A. - Hospital de Faro
      • Vila Real, Portugal, 5000-508
        • C. H. T. M. A. D. - Unidade Hospitalar de Vila Real

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital ambulatory patients

Description

Inclusion Criteria:

  • Patients diagnosed with post-stroke upper limb spasticity
  • Patients currently being treated with Dysport®, Botox® or Xeomin®
  • Patients stabilized from a therapeutic point of view - with no switches of treatment in at least the 2 last administrations
  • Patients who gave their written informed consent to participate.

Exclusion Criteria:

  • Not applicable.

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

Cohorts and Interventions

Group / Cohort
Dysport® (abobotulinumtoxinA)
Botulinum Toxin Type A (BoNT-A) preparation, injected doses, number of points, volume per point, in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines.
Botox® (onabotulinumtoxinA)
Botulinum Toxin Type A (BoNT-A) preparation, injected doses, number of points, volume per point, in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines.
Xeomin® (incobotulinumtoxinA)
Botulinum Toxin Type A (BoNT-A) preparation, injected doses, number of points, volume per point, in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the cost of botulinum toxin utilization
Time Frame: 12 months
Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of work days missed due to spasticity
Time Frame: 12 months
Assessment of Absenteeism /loss of productivity
12 months
Carer time needed for patient assistance
Time Frame: 12 months
12 months

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)

November 1, 2014

Primary Completion (Actual)

March 16, 2017

Study Completion (Actual)

March 16, 2017

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52120-188

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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