EPITOME
Research type
Research Study
Full title
A PROSPECTIVE, MULTICOUNTRY STUDY TO ESTIMATE THE INCIDENCE OF AND PROVIDE A BEST PRACTICE MODEL FOR MONITORING THE DEVELOPMENT OF POST-STROKE SPASTICITY
IRAS ID
330069
Contact name
Prasad Rama
Contact email
Sponsor organisation
Ipsen Pharma
Duration of Study in the UK
3 years, 3 months, 5 days
Research summary
This is a prospective, multicountry, multicentre, epidemiological study in adult participants aged 18 to 85 years presenting with weakness (know as paresis) within 2 weeks of a first-ever clinical stroke that has occurred within the past 4 weeks.
The primary purpose of the study is to determine the proportion of first-ever stroke patients with paresis who, within 1 year of stroke, develop problematic spasticity, that is a condition where muscles stiffen or tighten involuntarily, preventing normal movement, and sometimes causing discomfort or pain .
The current study will address important data gaps, providing systematic epidemiological information about the incidence of spasticity in stroke patients (location and severity of post-stroke paresis and the incidence, timing, severity and distribution of PSS - Post Stroke Spasticity), and collecting detailed information on the range of treatments planned for PSS and the reasons for treatment choices.
A total of approximately 1051 participants will be enrolled at approximately 35 sites across the United States of America (USA), the United Kingdom (UK), France, Spain, Sweden, Italy and Germany (approximately 5-10 sites per country).
Recruited participants will be patients who have experienced their first-ever stroke within the past 4 weeks and who have paresis of the arms and/or legs according to National Institutes of Health Stroke Scale (NIHSS) score within 2 weeks after the stroke.
The total planned study duration is up to 40 months: 22 months enrolment period and up to 18 months follow-up period (up to 12 months remote monitoring, a face-to-face (F2F) clinical confirmation Visit (CCV) up to 2 months after signs of possible spasticity detected and a treatment plan up to 4 months after the F2F CCV for participants who have confirmed spasticity at the CCV but not problematic spasticity).REC name
London - Bromley Research Ethics Committee
REC reference
23/PR/1206
Date of REC Opinion
30 Oct 2023
REC opinion
Further Information Favourable Opinion