Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke
Launched by IPSEN · May 11, 2015
Trial Information
Current as of June 30, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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).
About Ipsen
Ipsen is a global biopharmaceutical group dedicated to innovation and specialty care, focusing on the discovery, development, and commercialization of transformative medicines for patients with serious diseases. With a strong emphasis on oncology, neuroscience, and rare diseases, Ipsen leverages cutting-edge research and advanced technologies to deliver high-quality therapies that address unmet medical needs. Committed to scientific excellence and ethical practices, Ipsen collaborates with healthcare professionals and stakeholders to drive patient-centered solutions and improve health outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ciecierzyn, , Poland
Katowice, , Poland
Sandomierz, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wrocław, , Poland
Patients applied
Trial Officials
Ipsen Medical Director
Study Director
Ipsen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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