Clinical trial NCT02444494: Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Stroke Arm Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.

Brief 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. 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)
timeFrame: Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Secondary outcomes:
measure: Global assessment of spasticity by Modified Ashworth Scale (MAS)
timeFrame: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
measure: Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength
timeFrame: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
measure: To document cost of treatment with Dysport in these patients
timeFrame: Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Other outcomes:
Locations:
city: Ciecierzyn
country: Poland
facility: Indywidualna Praktyka lekarska
city: Katowice
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego
city: Sandomierz
country: Poland
facility: Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym
city: Szczecin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii
city: Warsaw
country: Poland
facility: II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii
city: Wrocław
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: