An Ischaemic Stroke Observational Study
- Conditions
- Stroke
- Registration Number
- NCT03333980
- Lead Sponsor
- ReNeuron Limited
- Brief Summary
A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke
- Detailed Description
Primary objective:
To document and better define the prognostic characteristics of residual disability 12 months or more following an ischaemic stroke in patients that originally participated in the preceding clinical study RN-CS-0001.
Other objective:
To inform the design of efficient Phase 2/3 studies when screening potentially efficacious interventions for signals of activity which merit further development.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- Capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments.
- Participation in the preceding study RN-CS-0001
- Completion of at least one of the 4 functional assessment tests (ARAT, BI, NIHSS, mRS) at any time point on the previous study RN-CS-0001
- Ability to participate in all assessments and attend all visits
- Any additional incidence of stroke (Ischaemic or Haemorrhagic) since participation in the previous study RN-CS-0001 (since the last CS-0001 assessment visit date).
- Incidence of significant other disease that judged by the investigator would confound completion of all functional assessments (not excluding patients that can complete at least one functional assessment with no confounding factor from significant other disease).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study 12-months Compare functional assessment scores collected in RN-CS-0002 with the preceding RN-CS-0001 study to better understand stroke symptom recovery and progress
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Ninewells Hospital & Medical School
🇬🇧Dundee, United Kingdom
New Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Queen Elizabeth University Hospital.
🇬🇧Glasgow, United Kingdom
University College London Hospital Stroke Research Centre
🇬🇧London, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
The University of Manchester Institute of Cardiovascular Research
🇬🇧Manchester, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom