An Ischaemic Stroke Observational Study

ReNeuron

Status: Completed

Conditions: Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT03333980

RN-CS-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Volunteers: No Healthy Volunteers

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).