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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-03-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Upper Limb Spasticity Post-Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.