A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
NCT ID: NCT06055725
Last Updated: 2025-12-30
Study Results
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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RECRUITING
1051 participants
OBSERVATIONAL
2023-11-01
2027-11-30
Brief Summary
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Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain.
The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication.
Spasticity is a common post-stroke condition that causes stiff or ridged muscles.
The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks;
* Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of \> 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke
* Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Exclusion Criteria
* Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
* Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
* Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
* Participation in any interventional study
18 Years
90 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Loma Linda
Anderson, California, United States
University Of California, Los Angeles Medical Center
Los Angeles, California, United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Florida City, Florida, United States
Knight Neurology
Rockledge, Florida, United States
Emory University Merge
Atlanta, Georgia, United States
Medstar Health Research Institute, Inc
Hyattsville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri Health Care
Columbia, Missouri, United States
Methodist Physicians Clinic
Omaha, Nebraska, United States
Madonna Rehabilitation Hospital - Omaha Campus
Omaha, Nebraska, United States
Duke University School of Medicine
Durham, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Moss Rehab
Elkins Park, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University Of Texas Southwestern Medical Center
Dallas, Texas, United States
McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location
Houston, Texas, United States
The University of Texas Health Science Center
San Antonio, Texas, United States
University Of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CHU Bordeaux-Hopital Pellegrin
Bordeaux, , France
CHU de Caen
Caen, , France
CHU de Rennes, Hopital de Pontchaillou
Rennes, , France
Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle
Saint-Genis-Laval, , France
CHU Nantes
Saint-Jacques, , France
Klinikum Altenburger Land GmbH
Altenburg, , Germany
Charité - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
Düsseldorf, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
Lübeck, , Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, , Germany
Universitaetsklinikum Tuebingen (UKT)
Tübingen, , Germany
Azienda Ospedaliero Universitaria OO RR di Foggia
Foggia, , Italy
Milan University, Humanitas Clinical Institute
Milan, , Italy
AOU maggiore della Carita'
Novara, , Italy
AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno
Salerno, , Italy
Neurological Rehabilitation Unit- Policlinico Borgo Roma.
Verona, , Italy
Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma
Verona, , Italy
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, , Spain
Hospital Mutua De Terrassa
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro
Vigo, , Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, , Spain
Angelholm Northern Hospital
Ängelholm, , Sweden
Sodra Alvsborgs Sjukhus
Borås, , Sweden
Skane University Hospital
Malmo, , Sweden
Karnsjukhuset Skaraborg
Skövde, , Sweden
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
Leicester, , United Kingdom
The Walton Centre
Liverpool, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
South Tees Hospitals Foundation Nhs Trust
Middlesbrough, , United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Methodist P Clinic
Role: primary
References
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Zorowitz RD, Barrenechea LS, Butet S, Groppa S, Hernandez Herrero D, Prasad R, Sandars S, Meloni S, Page S, Maisonobe P, Picelli A. How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol. BMJ Open. 2025 Jan 15;15(1):e087404. doi: 10.1136/bmjopen-2024-087404.
Other Identifiers
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CLIN-52120-458
Identifier Type: -
Identifier Source: org_study_id