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

Ipsen

Status: Completed

Conditions: Upper Limb Spasticity Post-Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT02384330

A-38-52120-188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

57 participants in 3 patient groups

Dysport® (abobotulinumtoxinA)

Description:

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)

Description:

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)

Description:

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.