Upper Limb Spasticity Post-Stroke Clinical Trial
— P_Dysport_CSOfficial title:
Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
| NCT number | NCT02384330 |
| Other study ID # | A-38-52120-188 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2014 |
| Est. completion date | March 16, 2017 |
| Verified date | January 2019 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | March 16, 2017 |
| Est. primary completion date | March 16, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Centro de Medicina de Reabilitação de Alcoitão | Alcabideche | |
| Portugal | C. H. A. - Hospital de Faro | Faro | |
| Portugal | C. H. T. M. A. D. - Unidade Hospitalar de Vila Real | Vila Real |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Portugal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Number of work days missed due to spasticity | Assessment of Absenteeism /loss of productivity | 12 months | |
| Secondary | Carer time needed for patient assistance | 12 months |