Status:
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
Lead Sponsor:
Ipsen
Conditions:
Spasticity as Sequela of Stroke
Eligibility:
All Genders
18-90 years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
1051 Patients enrolled
Trial Details
Trial ID
NCT06055725
Start Date
November 1 2023
End Date
November 30 2027
Last Update
December 30 2025
Active Locations (58)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda
Anderson, California, United States, 92354
2
University Of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
3
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Florida City, Florida, United States, 13330
4
Knight Neurology
Rockledge, Florida, United States, 32955