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Clinical Trials in Italy / NCT06055725
Active, not recruiting Observational

A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

NCT06055725 · tracked via the Priya Life Science Italy tracker
Sponsor
Ipsen
Phase
Observational
Started
2023-11-01
Last updated
2026-09-04

Condition(s) studied

Spasticity as Sequela of Stroke

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy — At the Clinical Confirmation Visit (CCV) up to maximum 18 months
    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.

Trial sites (55)

FacilityCityRegionStatus
Loma Linda Anderson California
Knight Neurology Rockledge Florida
Medstar Health Research Institute, Inc Hyattsville Maryland
Massachusetts General Hospital Boston Massachusetts
Spaulding Rehabilitation Hospital Boston Massachusetts
University of Missouri Health Care Columbia Missouri
Methodist Physicians Clinic Omaha Nebraska
Madonna Rehabilitation Hospital - Omaha Campus Omaha Nebraska
Las Vegas Neurology Center Las Vegas Nevada
Duke University School of Medicine Durham North Carolina
Dayton Center for Neurological Disorders Centerville Ohio
Moss Rehab Elkins Park Pennsylvania
Medical University of South Carolina Charleston South Carolina
The University Of Texas Southwestern Medical Center Dallas Texas
McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location Houston Texas
University Of Utah Salt Lake City Utah
Medical College of Wisconsin Milwauke Wisconsin
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
Ospedal Valduce Lecco 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

+ 15 more sites — see the full list on the official registry below.

More Ipsen trials in Italy

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment Active, not recruiting
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. Active, not recruiting
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment Recruiting
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis Recruiting
A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06055725 on ClinicalTrials.gov ↗ ← All trials in Italy