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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02384330
Acronym
P_Dysport_CS
Enrollment
57
Registered
2015-03-10
Start date
2014-11-30
Completion date
2017-03-16
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Limb Spasticity Post-Stroke

Brief summary

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.

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.

Interventions

None listed

Sponsors

Ipsen
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Estimate the cost of botulinum toxin utilization12 monthsDirect resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product

Secondary

MeasureTime frameDescription
Number of work days missed due to spasticity12 monthsAssessment of Absenteeism /loss of productivity
Carer time needed for patient assistance12 months

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026