Botulinum Toxin A Associated Costs in the Treatment of Upper Limb Spasticity Post Stroke
P_Dysport_CS
Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
1 other identifier
observational
57
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2014
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2017
CompletedJanuary 7, 2019
January 1, 2019
2.4 years
March 4, 2015
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Estimate the cost of botulinum toxin utilization
Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product
12 months
Secondary Outcomes (2)
Number of work days missed due to spasticity
12 months
Carer time needed for patient assistance
12 months
Study Arms (3)
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.
Eligibility Criteria
Hospital ambulatory patients
You may qualify if:
- 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.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (3)
Centro de Medicina de Reabilitação de Alcoitão
Alcabideche, 2649-506, Portugal
C. H. A. - Hospital de Faro
Faro, 8000-386, Portugal
C. H. T. M. A. D. - Unidade Hospitalar de Vila Real
Vila Real, 5000-508, Portugal
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 10, 2015
Study Start
November 1, 2014
Primary Completion
March 16, 2017
Study Completion
March 16, 2017
Last Updated
January 7, 2019
Record last verified: 2019-01