An Ischaemic Stroke Observational Study

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333980
• Other study ID #: RN-CS-0002
• Status: Completed
• Phase: N/A
• First received: September 26, 2017
• Last updated: December 1, 2017
• Start date: May 1, 2017
• Est. completion date: November 6, 2017

Study information

• Verified date: December 2017
• Source: ReNeuron Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United Kingdom	New Queen Elizabeth Hospital	Birmingham
United Kingdom	Ninewells Hospital & Medical School	Dundee
United Kingdom	Queen Elizabeth University Hospital.	Glasgow
United Kingdom	University College London Hospital Stroke Research Centre	London
United Kingdom	The University of Manchester Institute of Cardiovascular Research	Manchester
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
ReNeuron Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study	Compare functional assessment scores collected in RN-CS-0002 with the preceding RN-CS-0001 study to better understand stroke symptom recovery and progress	12-months