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

Last updated: April 29, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Limb Spasticity

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT06055725
CLIN-52120-458
  • Ages 18-90
  • All Genders

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 Criteria

Inclusion

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 criteriaas rapidly developing clinical signs of focal (at times global) disturbance ofcerebral 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)between Day 3 and day 14 after the stroke

  • Capable of giving informed consent which includes compliance with the requirementsand restrictions listed in the ICF and in this protocol

Exclusion

Exclusion Criteria:

  • Upper or lower extremity functional impairment prior to stroke per investigatorjudgement (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 couldhave caused paresis/spasticity/motor deficit per investigator judgement;

  • Life expectancy of less than 12 months as a result of severity of stroke or otherillnesses (e.g. cardiac disease, malignancy, etc.)

  • Participation in any interventional study

Study Design

Total Participants: 1051
Study Start date:
November 01, 2023
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • CHU Bordeaux-Hopital Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • CHU de Rennes, Hopital de Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle

    Saint-Genis-Laval, 69230
    France

    Active - Recruiting

  • CHU Nantes

    Saint-Jacques,
    France

    Active - Recruiting

  • Klinikum Altenburger Land GmbH

    Altenburg,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Luebeck, 23562
    Germany

    Active - Recruiting

  • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Azienda Ospedaliero Universitaria OO RR di Foggia

    Foggia, 71100
    Italy

    Active - Recruiting

  • AOU maggiore della Carita'

    Novara, 28100
    Italy

    Site Not Available

  • AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno

    Salerno, 84131
    Italy

    Active - Recruiting

  • Neurological Rehabilitation Unit- Policlinico Borgo Roma.

    Verona, 37134
    Italy

    Active - Recruiting

  • 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

    Active - Recruiting

  • Hospital Mutua De Terrassa

    Barcelona, 08221
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro

    Vigo, 36200
    Spain

    Active - Recruiting

  • Sodra Alvsborgs Sjukhus

    Borås, 50455
    Sweden

    Site Not Available

  • Skane University Hospital

    Malmö, 20502
    Sweden

    Active - Recruiting

  • Karnsjukhuset Skaraborg

    Skövde, 54185
    Sweden

    Active - Recruiting

  • Angelholm Northern Hospital

    Ängelholm, 26281
    Sweden

    Active - Recruiting

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

  • The Walton Centre

    Liverpool,
    United Kingdom

    Active - Recruiting

  • South Tees Hospitals Foundation Nhs Trust

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Loma Linda

    Anderson, California 92354
    United States

    Site Not Available

  • University Of California, Los Angeles Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)

    Florida City, Florida 13330
    United States

    Site Not Available

  • Emory University Merge

    Atlanta, Georgia 30329-2206
    United States

    Site Not Available

  • Medstar Health Research Institute, Inc

    Hyattsville, Maryland 20782
    United States

    Active - Recruiting

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts 02129
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Methodist Physicians Clinic

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Duke University School of Medicine

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Moss Rehab

    Elkins Park, Pennsylvania 19027
    United States

    Active - Recruiting

  • The University Of Texas Southwestern Medical Center

    Dallas, Texas 75390-8869
    United States

    Active - Recruiting

  • The University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University Of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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