Overview

This trial has been completed.

Condition post stroke arm spasticity
Sponsor Ipsen
Start date March 2015
End date September 2016
Trial size 108 participants
Trial identifier NCT02444494, A-38-52120-215

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ipsen.