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Search / Trial NCT02444494

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.

Locations

Ciecierzyn, , Poland

Katowice, , Poland

Sandomierz, , Poland

Szczecin, , Poland

Warsaw, , Poland

Wrocław, , Poland

Patients applied

0 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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