Upper Limb Spasticity Post-StrokeP_Dysport_CSNCT02384330
Botulinum Toxin A Associated Costs in the Treatment of Upper Limb Spasticity Post Stroke
An observational study of Upper Limb Spasticity Post-Stroke, run by Ipsen at 3 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Spasticity Post-Stroke
- How many people
- 57 participants
- Where
- 3 sitesPortugal
- Study dates
- Nov 2014to 16 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital ambulatory patients
Who may be able to join
- 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.
Who cannot join
- Not applicable.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Centro de Medicina de Reabilitação de Alcoitão
Alcabideche, 2649-506
C. H. A. - Hospital de Faro
Faro, 8000-386
C. H. T. M. A. D. - Unidade Hospitalar de Vila Real
Vila Real, 5000-508
About this study
Official title: Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
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.
Read the 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.
- Conditions
- Upper Limb Spasticity Post-Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the cost of botulinum toxin utilization
Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product
Measured: 12 months
Secondary outcomes (2)
Number of work days missed due to spasticity
Assessment of Absenteeism /loss of productivity
Measured: 12 months
Carer time needed for patient assistance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startNov 2014
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Spasticity Post-StrokeStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384330
- Sponsor's protocol ID
- A-38-52120-188
- Acronym
- P_Dysport_CS
- Status last verified
- Jan 2019
- First submitted
- 4 Mar 2015
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
- ClinicalTrials.gov ID
- NCT02384330
- Acronym / sponsor ID
- P_Dysport_CS / A-38-52120-188
- Conditions
- Upper Limb Spasticity Post-Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital ambulatory patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the cost of botulinum toxin utilization
Time frame: 12 months
Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product
2 secondary outcomes
Number of work days missed due to spasticity
Time frame: 12 months
Carer time needed for patient assistance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Spasticity Post-Stroke, run by Ipsen at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the cost of botulinum toxin utilization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.