Post Stroke Arm SpasticityPSAS REGISTRYNCT02444494
Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke
An observational study of Post Stroke Arm Spasticity, run by Ipsen at 6 sites in Poland.
Trial summary
The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke Arm Spasticity
- How many people
- 108 participants
- Where
- 6 sitesPoland
- Study dates
- Mar 2015to Sep 2016
- How long will I take part?
- 9 Months
- 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: Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.
Who may be able to join
- ≥ 18 years of age.
- A history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital.
- Post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified Ashworth scale - MAS ≥ 2) in at least one muscle group.
- Classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services.
- Drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation.
- Written informed consent given by patient before any occurrence of study related procedure.
- Patient has been already included in a NHF Dysport programme.
Who cannot join
- Severe dysphagia and respiratory disorders.
- Pregnancy
- Myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases).
- Generalized symptoms of infection
- The presence of inflammation within the planned sites of administration.
- Fixed contractures in the soft tissues and joints.
- Dementia medium or deep cycle (score on mini mental state examination (MMSE) equal to or less than 18 points).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Poland6 sites
Indywidualna Praktyka lekarska
Ciecierzyn, 21-003
Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego
Katowice, 40-752, ul Medyków 14
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym
Sandomierz, 27-600 Schinzla 13
Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii
Szczecin, Chopina 22, 71-450
II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii
Warsaw, Sobieskiego 9, 02-957
Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego
Wroclaw, 51-149 KOSZAROWA 5
About this study
Official title: Observational Prospective Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke, Under Conditions of Routine Clinical Practice
The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to collect data in patients scheduled to receive Dysport treatment in a drug programme, based on routine treatment of subject with ULS.
- Conditions
- Post Stroke Arm Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)
Clinical Global Impression of Improvement (CGI-I) scale: 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.
Measured: Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Secondary outcomes (3)
Global assessment of spasticity by Modified Ashworth Scale (MAS)
MAS - spasticity scores at each joint: shoulder, elbow, wrist, finger, thumb
Measured: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength
Measured: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
To document cost of treatment with Dysport in these patients
Direct costs associated with the administration of Dysport will include the dose of Dysport, interval between reinjections, cost of healthcare resources: needles, syringes, identification techniques of the muscles.
Measured: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Arm 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
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 9 Months
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
- NCT02444494
- Sponsor's protocol ID
- A-38-52120-215
- Acronym
- PSAS REGISTRY
- Status last verified
- Dec 2018
- First submitted
- 28 Apr 2015
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke, Under Conditions of Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02444494
- Acronym / sponsor ID
- PSAS REGISTRY / A-38-52120-215
- Conditions
- Post Stroke Arm Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 May 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.
The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to collect data in patients scheduled to receive Dysport treatment in a drug programme, based on routine treatment of subject with ULS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.
Key inclusion criteria (7 listed)
- ≥ 18 years of age.
- A history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital.
- Post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified Ashworth scale - MAS ≥ 2) in at least one muscle group.
- Classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services.
- Drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation.
Key exclusion criteria (7 listed)
- Severe dysphagia and respiratory disorders.
- Pregnancy
- Myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases).
- Generalized symptoms of infection
- The presence of inflammation within the planned sites of administration.
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
Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)
Time frame: Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Clinical Global Impression of Improvement (CGI-I) scale: 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.
3 secondary outcomes
Global assessment of spasticity by Modified Ashworth Scale (MAS)
Time frame: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength
Time frame: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
To document cost of treatment with Dysport in these patients
Time frame: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
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 21 Dec 2018.
Related trials for Post Stroke Arm Spasticity
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FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
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A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
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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
6 sites 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 Arm Spasticity, run by Ipsen at 6 sites in Poland.
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 7 inclusion and 7 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. 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?
Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I) (time frame: Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)). 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 21 Dec 2018.