Post Stroke SpasticityRelaxNCT04649632
Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
An observational study of Post Stroke Spasticity, run by Ipsen at 1 site in Netherlands.
Trial summary
Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Post Stroke Spasticity
- How many people
- 451 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Apr 2020to 18 Sep 2020
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients selected from the database claimed within the code 313 will be included in the descriptive analyses.
Who may be able to join
- A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox
Who cannot join
- A patient will be excluded if he has been only treated with Xeomin
Trial locations and contacts
1 site in 1 country.
About this study
Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.
- Conditions
- Post Stroke Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to next injection per brand
Measured: From baseline up to end of data collection (January 2012 up to December 2016)
Median time to next injection per brand
Measured: From baseline up to end of data collection (January 2012 up to December 2016)
Dosing of botulinum toxin-A in daily practice in relation to time to next injection
Measured: From baseline up to end of data collection (January 2012 up to December 2016)
Secondary outcomes (3)
Average cost per year per brand per patient
Measured: From baseline up to end of data collection (January 2012 up to December 2016)
Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments
Measured: From baseline up to end of data collection (January 2012 up to December 2016)
Time interval between 2 injections of the same brand
Measured: From baseline up to end of data collection (January 2012 up to December 2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start29 Apr 2020
- Primary completion18 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke SpasticityStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 451 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
- NCT04649632
- Sponsor's protocol ID
- CLIN-52120-450
- Acronym
- Relax
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
- ClinicalTrials.gov ID
- NCT04649632
- Acronym / sponsor ID
- Relax / CLIN-52120-450
- Conditions
- Post Stroke Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 2 Dec 2020 (actual)
- 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.
Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients selected from the database claimed within the code 313 will be included in the descriptive analyses.
Key inclusion criteria (1 listed)
- A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox
Key exclusion criteria (1 listed)
- A patient will be excluded if he has been only treated with Xeomin
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
Mean time to next injection per brand
Time frame: From baseline up to end of data collection (January 2012 up to December 2016)
Median time to next injection per brand
Time frame: From baseline up to end of data collection (January 2012 up to December 2016)
Dosing of botulinum toxin-A in daily practice in relation to time to next injection
Time frame: From baseline up to end of data collection (January 2012 up to December 2016)
3 secondary outcomes
Average cost per year per brand per patient
Time frame: From baseline up to end of data collection (January 2012 up to December 2016)
Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments
Time frame: From baseline up to end of data collection (January 2012 up to December 2016)
Time interval between 2 injections of the same brand
Time frame: From baseline up to end of data collection (January 2012 up to December 2016)
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 2 Dec 2020.
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FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
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ESTIM-UL: FES for Upper Limb Recovery After Stroke
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Stroke Spasticity, run by Ipsen at 1 site in Netherlands.
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 1 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Mean time to next injection per brand (time frame: From baseline up to end of data collection (January 2012 up to December 2016)). The study lists 3 primary outcomes in all. 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 2 Dec 2020.