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: March 2, 2026
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) within 2 weeks 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:
November 30, 2027

Connect with a study center

  • CHU Bordeaux-Hopital Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • CHU Bordeaux-Hopital Pellegrin

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • CHU de Caen

    Caen 3029241, 14033
    France

    Site Not Available

  • CHU de Rennes, Hopital de Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • CHU de Rennes, Hopital de Pontchaillou

    Rennes 2983990, 35033
    France

    Site Not Available

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

    Saint-Genis-Laval, 69230
    France

    Active - Recruiting

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

    Saint-Genis-Laval 2979985, 69230
    France

    Site Not Available

  • CHU Nantes

    Saint-Jacques,
    France

    Active - Recruiting

  • CHU Nantes

    Saint-Jacques 2979426,
    France

    Site Not Available

  • Klinikum Altenburger Land GmbH

    Altenburg,
    Germany

    Active - Recruiting

  • Klinikum Altenburger Land GmbH

    Altenburg 2957773,
    Germany

    Site Not Available

  • Charité - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117
    Germany

    Active - Recruiting

  • Charité - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • University Hospital Carl Gustav Carus

    Dresden,
    Germany

    Active - Recruiting

  • University Hospital Carl Gustav Carus

    Dresden 2935022,
    Germany

    Site Not Available

  • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)

    Düsseldorf,
    Germany

    Active - Recruiting

  • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)

    Düsseldorf 2934246,
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel 2891122, 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Luebeck, 23562
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Lübeck, 23562
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Lübeck 2875601, 23562
    Germany

    Site Not Available

  • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

    Mainz 2874225, 55131
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen (UKT)

    Tübingen,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Tuebingen (UKT)

    Tübingen 2820860,
    Germany

    Site Not Available

  • Azienda Ospedaliero Universitaria OO RR di Foggia

    Foggia, 71100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria OO RR di Foggia

    Foggia 3176885, 71100
    Italy

    Site Not Available

  • Ospedal Valduce

    Lecco, 23845
    Italy

    Active - Recruiting

  • Milan University, Humanitas Clinical Institute

    Milan,
    Italy

    Active - Recruiting

  • Milan University, Humanitas Clinical Institute

    Milan 6951411,
    Italy

    Site Not Available

  • AOU maggiore della Carita'

    Novara, 28100
    Italy

    Site Not Available

  • AOU maggiore della Carita'

    Novara 3172189, 28100
    Italy

    Site Not Available

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

    Salerno, 84131
    Italy

    Active - Recruiting

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

    Salerno 3168673, 84131
    Italy

    Site Not Available

  • 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

  • Neurological Rehabilitation Unit- Policlinico Borgo Roma.

    Verona 3164527, 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 3164527,
    Italy

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona,
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona 3129028,
    Spain

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Mutua De Terrassa

    Barcelona, 08221
    Spain

    Active - Recruiting

  • Hospital Clinic i Provincial

    Barcelona 3128760,
    Spain

    Site Not Available

  • Hospital Mutua De Terrassa

    Barcelona 3128760, 08221
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

    Madrid 3117735,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro

    Vigo, 36200
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro

    Vigo 3105976, 36200
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet de Zaragoza

    Zaragoza,
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet de Zaragoza

    Zaragoza 3104324,
    Spain

    Site Not Available

  • Sodra Alvsborgs Sjukhus

    Borås, 50455
    Sweden

    Completed

  • Sodra Alvsborgs Sjukhus

    Borås 2720501, 50455
    Sweden

    Site Not Available

  • Skane University Hospital

    Malmo, 20502
    Sweden

    Active - Recruiting

  • Skane University Hospital

    Malmo 2692969, 20502
    Sweden

    Site Not Available

  • Skane University Hospital

    Malmö, 20502
    Sweden

    Site Not Available

  • Karnsjukhuset Skaraborg

    Skövde, 54185
    Sweden

    Active - Recruiting

  • Karnsjukhuset Skaraborg

    Skövde 2677234, 54185
    Sweden

    Site Not Available

  • Angelholm Northern Hospital

    Ängelholm, 26281
    Sweden

    Active - Recruiting

  • Angelholm Northern Hospital

    Ängelholm 2725901, 26281
    Sweden

    Site Not Available

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

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

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

    Leicester 2644668, LE5 4PW
    United Kingdom

    Site Not Available

  • The Walton Centre

    Liverpool,
    United Kingdom

    Active - Recruiting

  • The Walton Centre

    Liverpool 2644210,
    United Kingdom

    Site Not Available

  • Kings College Hospital NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Kings College Hospital NHS Foundation Trust

    London 2643743,
    United Kingdom

    Site Not Available

  • South Tees Hospitals Foundation Nhs Trust

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • South Tees Hospitals Foundation Nhs Trust

    Middlesbrough 2642607,
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham 2641170,
    United Kingdom

    Site Not Available

  • 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

  • Loma Linda

    Anderson 5558857, California 5332921 92354
    United States

    Site Not Available

  • University Of California, Los Angeles Medical Center

    Los Angeles 5368361, California 5332921 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

  • Knight Neurology

    Rockledge, Florida 32955
    United States

    Active - Recruiting

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

    Florida City 4155669, Florida 4155751 13330
    United States

    Site Not Available

  • Knight Neurology

    Rockledge 4170358, Florida 4155751 32955
    United States

    Site Not Available

  • Emory University Merge

    Atlanta, Georgia 30329-2206
    United States

    Site Not Available

  • Emory University Merge

    Atlanta 4180439, Georgia 4197000 30329-2206
    United States

    Site Not Available

  • Medstar Health Research Institute, Inc

    Hyattsville, Maryland 20782
    United States

    Active - Recruiting

  • Medstar Health Research Institute, Inc

    Hyattsville 4358821, Maryland 4361885 20782
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts 02129
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Spaulding Rehabilitation Hospital

    Boston 4930956, Massachusetts 6254926 02129
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri Health Care

    Columbia 4381982, Missouri 4398678 65212
    United States

    Site Not Available

  • Madonna Rehabilitation Hospital - Omaha Campus

    Omaha, Nebraska 68118
    United States

    Active - Recruiting

  • Methodist Physicians Clinic

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Madonna Rehabilitation Hospital - Omaha Campus

    Omaha 5074472, Nebraska 5073708 68118
    United States

    Site Not Available

  • Methodist Physicians Clinic

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Active - Recruiting

  • Duke University School of Medicine

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Duke University School of Medicine

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Dayton Center for Neurological Disorders

    Centerville, Ohio 45459
    United States

    Active - Recruiting

  • Dayton Center for Neurological Disorders

    Centerville 4508204, Ohio 5165418 45459
    United States

    Site Not Available

  • Moss Rehab

    Elkins Park, Pennsylvania 19027
    United States

    Active - Recruiting

  • Moss Rehab

    Elkins Park 5188546, Pennsylvania 6254927 19027
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • The University Of Texas Southwestern Medical Center

    Dallas, Texas 75390-8869
    United States

    Active - Recruiting

  • McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • The University Of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390-8869
    United States

    Site Not Available

  • McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • University Of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University Of Utah

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwauke, Wisconsin 53226
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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