NCT06055725Active, not recruiting
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1057 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Ipsen
- Diseases
- Stroke
- NCT number
- NCT06055725
What you commit to
- Study type: Observational
- Planned participants: 1057
- From 1 Nov 2023 to the primary completion date, 30 Nov 2027
- 55 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2);
Other illness
- 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.)
Other
- Participation in any interventional study
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (55)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Altenburger Land GmbH Coordinator of this site? Confirm its status | Altenburg | Germany | Unknown status |
| Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University Hospital Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD) Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitaetsklinikum Tuebingen (Ukt) Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Hospital Universitari Germans Trias I Pujol (Hugtp) Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Clinic i Provincial Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Mutua De Terrassa Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Hospital Universitario Miguel Servet de Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| CHU Bordeaux - Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU de CAEN Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU de Rennes, Hopital de Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle Coordinator of this site? Confirm its status | Saint-Genis-Laval | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Saint-Jacques | France | Unknown status |
| University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH) Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| The Walton Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Kings College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| South Tees Hospitals Foundation Nhs Trust Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust - Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Azienda Ospedaliero Universitaria OO RR di Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Ospedal Valduce Coordinator of this site? Confirm its status | Lecco | Italy | Unknown status |
| Milan University, Humanitas Clinical Institute Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| AOU "Maggiore della Carità" Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
| Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Neurological Rehabilitation Unit- Policlinico Borgo Roma. Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Angelholm Northern Hospital Coordinator of this site? Confirm its status | Ängelholm | Sweden | Unknown status |
| Södra Älvsborgs Sjukhus Coordinator of this site? Confirm its status | Borås | Sweden | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karnsjukhuset Skaraborg Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
| Loma Linda Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Spaulding Rehabilitation Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dayton Center for Neurological Disorders Coordinator of this site? Confirm its status | Centerville | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Missouri Health Care Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke University School of Medicine Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Moss Rehab Coordinator of this site? Confirm its status | Elkins Park | United States | Unknown status |
| McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Medstar Health Research Institute, Inc Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
| Las Vegas Neurology Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwauke | United States | Unknown status |
| Madonna Rehabilitation Hospital - Omaha Campus Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Methodist Physicians Clinic Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Knight Neurology Coordinator of this site? Confirm its status | Rockledge | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.