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Completed

NCT Number: NCT03333980

An Ischaemic Stroke Observational Study

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

New Queen Elizabeth Hospital, Birmingham, United Kingdom

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ReNeuron Limited

Industry

Registry information

Official study title

A Non-interventional Observational Clinical Study to Document the Clinical Course of Patients 12 Months or More Following an Ischaemic Stroke

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2017
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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