Sign in

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

Full criteria on ClinicalTrials.gov

Sites (55)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Klinikum Altenburger Land GmbH
Coordinator of this site? Confirm its status
AltenburgGermanyUnknown status
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
University Hospital Carl Gustav Carus
Coordinator of this site? Confirm its status
DresdenGermanyUnknown status
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
Universitaetsklinikum - Essen
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Coordinator of this site? Confirm its status
KielGermanyUnknown status
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Coordinator of this site? Confirm its status
LübeckGermanyUnknown status
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Coordinator of this site? Confirm its status
MainzGermanyUnknown status
Universitaetsklinikum Tuebingen (Ukt)
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status
Hospital Universitari Germans Trias I Pujol (Hugtp)
Coordinator of this site? Confirm its status
BadalonaSpainUnknown status
Hospital Clinic i Provincial
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Mutua De Terrassa
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Universitario Virgen del Rocio
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro
Coordinator of this site? Confirm its status
VigoSpainUnknown status
Hospital Universitario Miguel Servet de Zaragoza
Coordinator of this site? Confirm its status
ZaragozaSpainUnknown status
CHU Bordeaux - Hopital Pellegrin
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
CHU de CAEN
Coordinator of this site? Confirm its status
CaenFranceUnknown status
CHU de Rennes, Hopital de Pontchaillou
Coordinator of this site? Confirm its status
RennesFranceUnknown status
Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle
Coordinator of this site? Confirm its status
Saint-Genis-LavalFranceUnknown status
CHU Nantes
Coordinator of this site? Confirm its status
Saint-JacquesFranceUnknown status
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
The Walton Centre
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomUnknown status
Kings College Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
South Tees Hospitals Foundation Nhs Trust
Coordinator of this site? Confirm its status
MiddlesbroughUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
Azienda Ospedaliero Universitaria OO RR di Foggia
Coordinator of this site? Confirm its status
FoggiaItalyUnknown status
Ospedal Valduce
Coordinator of this site? Confirm its status
LeccoItalyUnknown status
Milan University, Humanitas Clinical Institute
Coordinator of this site? Confirm its status
MilanItalyUnknown status
AOU "Maggiore della Carità"
Coordinator of this site? Confirm its status
NovaraItalyUnknown status
AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno
Coordinator of this site? Confirm its status
SalernoItalyUnknown 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
VeronaItalyUnknown status
Neurological Rehabilitation Unit- Policlinico Borgo Roma.
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
Angelholm Northern Hospital
Coordinator of this site? Confirm its status
ÄngelholmSwedenUnknown status
Södra Älvsborgs Sjukhus
Coordinator of this site? Confirm its status
BoråsSwedenUnknown status
Skåne University Hospital
Coordinator of this site? Confirm its status
MalmöSwedenUnknown status
Karnsjukhuset Skaraborg
Coordinator of this site? Confirm its status
SkövdeSwedenUnknown status
Loma Linda
Coordinator of this site? Confirm its status
AndersonUnited StatesUnknown status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Spaulding Rehabilitation Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Dayton Center for Neurological Disorders
Coordinator of this site? Confirm its status
CentervilleUnited StatesUnknown status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
University of Missouri Health Care
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
The University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Duke University School of Medicine
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Moss Rehab
Coordinator of this site? Confirm its status
Elkins ParkUnited StatesUnknown status
McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Medstar Health Research Institute, Inc
Coordinator of this site? Confirm its status
HyattsvilleUnited StatesUnknown status
Las Vegas Neurology Center
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeUnited StatesUnknown status
Madonna Rehabilitation Hospital - Omaha Campus
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Methodist Physicians Clinic
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Knight Neurology
Coordinator of this site? Confirm its status
RockledgeUnited StatesUnknown status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.