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

Running, not enrolling

Conditions studied: Spasticity as Sequela of Stroke

In brief

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.

Key facts

Study ID

NCT06055725

Run by

Ipsen

People needed

1058

Starts

2023-11-01

Expected to finish

2027-11-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sodra Alvsborgs Sjukhus — Borås, Sweden
• Skane University Hospital — Malmö, Sweden
• Karnsjukhuset Skaraborg — Skövde, Sweden
• Loma Linda — Anderson, California, United States
• Knight Neurology — Rockledge, Florida, United States
• Medstar Health Research Institute, Inc — Hyattsville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Methodist Physicians Clinic — Omaha, Nebraska, United States
• Madonna Rehabilitation Hospital - Omaha Campus — Omaha, Nebraska, United States
• Las Vegas Neurology Center — Las Vegas, Nevada, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Dayton Center for Neurological Disorders — Centerville, Ohio, United States
• Moss Rehab — Elkins Park, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University Of Texas Southwestern Medical Center — Dallas, Texas, United States
• McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location — Houston, Texas, United States
• University Of Utah — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• 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
• Angelholm Northern Hospital — Ängelholm, Sweden

Full record on ClinicalTrials.gov

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