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Completed

NCT Number: NCT02384330

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

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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Key information

Conditions

Upper Limb Spasticity Post-Stroke

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Medicina de Reabilitação de Alcoitão, Alcabideche, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of work days missed due to spasticity

    Time frame: 12 months

    Assessment of Absenteeism /loss of productivity

  2. Carer time needed for patient assistance

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: P_Dysport_CS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2015
Registry last updated
Jan 7, 2019

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.

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