Overview

This trial is active, not recruiting.

Condition upper limb spasticity post-stroke
Sponsor Ipsen
Start date November 2014
End date March 2017
Trial size 57 participants
Trial identifier NCT02384330, A-38-52120-188

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Arm
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.
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.
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.

Primary Outcomes

Measure
Estimate the cost of botulinum toxin utilization
time frame: 12 months

Secondary Outcomes

Measure
Number of work days missed due to spasticity
time frame: 12 months
Carer time needed for patient assistance
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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:

Additional Information

Official title Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ipsen.