A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
EPITOME
A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity
1 other identifier
observational
1,058
7 countries
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
May 1, 2026
April 1, 2026
4.1 years
September 20, 2023
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy
This is based on the investigator's clinical judgement and could include spasticity characterised by any of the following criteria aligned with the World Health Organization International Classification of Functioning, Disability and Health in three dimensions: Impairment, Activity limitations \& Restriction on participation.
At the Clinical Confirmation Visit (CCV) up to maximum 18 months
Secondary Outcomes (17)
Distribution of National Institutes of Health Stroke Scale (NIHSS) scores
At enrollment
Percentage of participants who develop signs of possible spasticity
At Week 2, Month 1, Month 2, and every 3 months up to Month 12.
Percentage of participants who develop clinically confirmed spasticity
Week 2 to Month 14
Time from first ever stroke to detection of signs of possible spasticity
Week 2 to Month12
Time from first ever stroke to onset of clinically confirmed spasticity
Week 2 to Month 14
- +12 more secondary outcomes
Eligibility Criteria
The Main Population will be participants aged 18 to 90 years with confirmed paresis within 2 weeks after a first-ever clinical stroke that has occurred within the past 4 weeks
You may qualify if:
- 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
You may not qualify if:
- Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2);
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (54)
Loma Linda
Anderson, California, 92354, United States
Knight Neurology
Rockledge, Florida, 32955, United States
Medstar Health Research Institute, Inc
Hyattsville, Maryland, 20782, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Methodist Physicians Clinic
Omaha, Nebraska, 68114, United States
Madonna Rehabilitation Hospital - Omaha Campus
Omaha, Nebraska, 68118, United States
Duke University School of Medicine
Durham, North Carolina, 27705, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Moss Rehab
Elkins Park, Pennsylvania, 19027, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The University Of Texas Southwestern Medical Center
Dallas, Texas, 75390-8869, United States
McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location
Houston, Texas, 77030, United States
University Of Utah
Salt Lake City, Utah, 84112, United States
Medical College of Wisconsin
Milwauke, Wisconsin, 53226, United States
CHU Bordeaux-Hopital Pellegrin
Bordeaux, 33076, France
CHU de Caen
Caen, 14033, France
CHU de Rennes, Hopital de Pontchaillou
Rennes, 35033, France
Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle
Saint-Genis-Laval, 69230, France
CHU Nantes
Saint-Jacques, France
Klinikum Altenburger Land GmbH
Altenburg, Germany
Charité - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
Düsseldorf, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, 24105, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
Lübeck, 23562, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, 55131, Germany
Universitaetsklinikum Tuebingen (UKT)
Tübingen, Germany
Azienda Ospedaliero Universitaria OO RR di Foggia
Foggia, 71100, Italy
Ospedal Valduce
Lecco, 23845, Italy
Milan University, Humanitas Clinical Institute
Milan, Italy
AOU maggiore della Carita'
Novara, 28100, Italy
AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno
Salerno, 84131, Italy
Neurological Rehabilitation Unit- Policlinico Borgo Roma.
Verona, 37134, 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, 08221, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro
Vigo, 36200, Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, Spain
Angelholm Northern Hospital
Ängelholm, 26281, Sweden
Sodra Alvsborgs Sjukhus
Borås, 50455, Sweden
Skane University Hospital
Malmö, 20502, Sweden
Karnsjukhuset Skaraborg
Skövde, 54185, Sweden
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
Leicester, LE5 4PW, 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
Related Publications (1)
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.
PMID: 39819949DERIVED
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
September 28, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.