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An Ischaemic Stroke Observational Study

Sponsor
ReNeuron Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03333980
Collaborator
(none)
39
Enrollment
7
Locations
6.2
Actual Duration (Months)
5.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    39 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Non-interventional Observational Clinical Study to Document the Clinical Course of Patients 12 Months or More Following an Ischaemic Stroke
    Actual Study Start Date :
    May 1, 2017
    Actual Primary Completion Date :
    Nov 6, 2017
    Actual Study Completion Date :
    Nov 6, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Queen Elizabeth Hospital Birmingham United Kingdom
    2 Ninewells Hospital & Medical School Dundee United Kingdom
    3 Queen Elizabeth University Hospital. Glasgow United Kingdom
    4 University College London Hospital Stroke Research Centre London United Kingdom
    5 The University of Manchester Institute of Cardiovascular Research Manchester United Kingdom
    6 Nottingham City Hospital Nottingham United Kingdom
    7 University Hospital Southampton NHS Foundation Trust Southampton United Kingdom

    Sponsors and Collaborators

    • ReNeuron Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ReNeuron Limited
    ClinicalTrials.gov Identifier:
    NCT03333980
    Other Study ID Numbers:
    • RN-CS-0002
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Dec 5, 2017
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Dec 5, 2017