A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity

Status: Recruiting
Location: See all (51) locations...
Study Type: Observational
SUMMARY

This study will monitor patients during the first year following their stroke. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Participant must be aged 18 to 90 years at the time of providing informed consent

• 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

Locations
United States
California
Loma Linda
NOT_YET_RECRUITING
Anderson
University Of California, Los Angeles Medical Center
WITHDRAWN
Los Angeles
Florida
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
WITHDRAWN
Florida City
Georgia
Emory University Merge
WITHDRAWN
Atlanta
Massachusetts
Massachusetts General Hospital
ACTIVE_NOT_RECRUITING
Boston
Spaulding Rehabilitation Hospital
RECRUITING
Boston
Maryland
Medstar Health Research Institute, Inc
RECRUITING
Hyattsville
Minnesota
Mayo Clinic
WITHDRAWN
Rochester
Missouri
University of Missouri Health Care
RECRUITING
Columbia
North Carolina
Duke University School of Medicine
RECRUITING
Durham
Nebraska
Madonna Rehabilitation Hospital - Omaha Campus
ACTIVE_NOT_RECRUITING
Omaha
Methodist Physicians Clinic
RECRUITING
Omaha
Pennsylvania
Moss Rehab
RECRUITING
Elkins Park
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
The University Of Texas Southwestern Medical Center
RECRUITING
Dallas
McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location
ACTIVE_NOT_RECRUITING
Houston
The University of Texas Health Science Center
WITHDRAWN
San Antonio
Utah
University Of Utah
RECRUITING
Salt Lake City
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwauke
Other Locations
France
CHU Bordeaux-Hopital Pellegrin
RECRUITING
Bordeaux
CHU de Caen
RECRUITING
Caen
CHU de Rennes, Hopital de Pontchaillou
RECRUITING
Rennes
Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle
RECRUITING
Saint-genis-laval
CHU Nantes
RECRUITING
Saint-jacques
Germany
Klinikum Altenburger Land GmbH
RECRUITING
Altenburg
University Hospital Carl Gustav Carus
RECRUITING
Dresden
Universitaetsklinikum Essen
RECRUITING
Essen
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
RECRUITING
Kiel
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
RECRUITING
Lübeck
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
RECRUITING
Mainz
Italy
Azienda Ospedaliero Universitaria OO RR di Foggia
RECRUITING
Foggia
Milan University, Humanitas Clinical Institute
RECRUITING
Milan
AOU maggiore della Carita'
ACTIVE_NOT_RECRUITING
Novara
AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno
RECRUITING
Salerno
Neurological Rehabilitation Unit- Policlinico Borgo Roma.
RECRUITING
Verona
Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma
RECRUITING
Verona
Spain
Hospital Universitari Germans Trias i Pujol (HUGTP)
RECRUITING
Badalona
Hospital Mutua De Terrassa
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro
RECRUITING
Vigo
Hospital Universitario Miguel Servet de Zaragoza
RECRUITING
Zaragoza
Sweden
Angelholm Northern Hospital
RECRUITING
Ängelholm
Sodra Alvsborgs Sjukhus
COMPLETED
Borås
Skane University Hospital
RECRUITING
Malmo
Karnsjukhuset Skaraborg
RECRUITING
Skövde
United Kingdom
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
RECRUITING
Leicester
The Walton Centre
RECRUITING
Liverpool
Kings College Hospital NHS Foundation Trust
RECRUITING
London
South Tees Hospitals Foundation Nhs Trust
RECRUITING
Middlesbrough
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
RECRUITING
Nottingham
Contact Information
Primary
Ipsen Clinical Study Enquiries
clinical.trials@ipsen.com
See e mail
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 1051
Related Therapeutic Areas
Sponsors
Leads: Ipsen

This content was sourced from clinicaltrials.gov