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

Completed

• Conditions: Upper Limb Spasticity Post-Stroke

• Registration Number: NCT02384330
• Lead Sponsor: Ipsen

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Primary Completion: 2017-03-16
• Study Completion: 2017-03-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the cost of botulinum toxin utilization	12 months	Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product

Secondary Outcome Measures

Name	Time	Method
Carer time needed for patient assistance	12 months
Number of work days missed due to spasticity	12 months	Assessment of Absenteeism /loss of productivity

Trial Locations

Locations (3)

Centro de Medicina de Reabilitação de Alcoitão; 🇵🇹 Alcabideche, Portugal

C. H. T. M. A. D. - Unidade Hospitalar de Vila Real; 🇵🇹 Vila Real, Portugal

C. H. A. - Hospital de Faro; 🇵🇹 Faro, Portugal