Post Stroke Arm Spasticity Clinical Trial
— PSAS REGISTRYOfficial 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
| NCT number | NCT02444494 |
| Other study ID # | A-38-52120-215 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2015 |
| Est. completion date | September 2016 |
| Verified date | December 2018 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - = 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. Exclusion Criteria: - 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). |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Indywidualna Praktyka lekarska | Ciecierzyn | |
| Poland | Samodzielny Publiczny Centralny Szpital Kliniczny im, Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Neurologii Wieku Podeszlego | Katowice | |
| Poland | Samodzielny Publiczny Zespól Zakladów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddzial Neurologii z Pododdzialem Udarowym | Sandomierz | |
| Poland | Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii | Szczecin | |
| Poland | II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii | Warsaw | |
| Poland | Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego | Wroclaw |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation) | |
| Secondary | Global assessment of spasticity by Modified Ashworth Scale (MAS) | MAS - spasticity scores at each joint: shoulder, elbow, wrist, finger, thumb | Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation) | |
| Secondary | Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength | Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation) | ||
| Secondary | 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. | Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation) |