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Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke

NCT ID: NCT02444494

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Stroke Arm Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Indywidualna Praktyka lekarska

Ciecierzyn, , Poland

Site Status

Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego

Katowice, , Poland

Site Status

Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym

Sandomierz, , Poland

Site Status

Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii

Szczecin, , Poland

Site Status

II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii

Warsaw, , Poland

Site Status

Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego

Wroclaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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A-38-52120-215

Identifier Type: -

Identifier Source: org_study_id