NCT01859572

Completed

Observational Study of Ischaemic Stroke

ReNeuron Limited Source

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Other study identifiers

Sponsor study identifier

RN-CS-0001

Study Type

observational

Actual enrollment (reported)

110

Locations

1 country

Sites

1

Timeline

Study Start

February 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2016

Actual (reported)

Study Completion

May 2016

Actual (reported)

Brief Summary

The rationale for this study is to facilitate future Phase II/III clinical trials and improve outcome for patients suffering residual disability after an ischaemic stroke. Main study objectives are to document and better define the prognostic characteristics of residual disability in patients following an ischaemic stroke, to inform the design of small efficient Phase II studies when screening potentially efficacious interventions for signals of activity which merit further development and to establish a pool of patients who may be approached to participate in future clinical trials in the ischaemic stroke setting.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 110 participants
Study completion date: May 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 15, 2013
Actual (reported)
First Posted
May 22, 2013
Actual (reported)
Study Start
February 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)
Study Completion
May 2016
Actual (reported)

Last Updated: December 19, 2016
Status Verified: December 2016
Last Update Submitted: December 16, 2016

Conditions

Motor Activity Stroke

Keywords

StrokeCerebral InfarctionBrain DisordersCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain Ischaemia

Outcome Measures

Primary Outcomes (4)

Action Research Arm Test (ARAT)
6 months
National Institute of Health Stroke Scale (NIHSS)
6 months
modified Rankin Scale (mRS)
6 months
Barthel Index (BI)
6 months

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The group consists of consenting patients who survive the first 7 days following their first ischaemic stroke in participating stroke units

You may qualify if:

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

Sponsors & Collaborators

ReNeuron Limited
Industrylead

Study Sites (1)

Glasgow Southern General Hospital

Glasgow, G51 4TF, United Kingdom

MeSH Terms

Conditions

StrokeMotor ActivityCerebral InfarctionBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBehaviorBrain IschemiaInfarctionIschemiaPathologic Processes

Enrollment

110 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 22, 2013

Study Start

February 2014

Date type not reported

This date has not been verified as actual or estimated.

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Phase 2Completed

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A Rehabilitation Therapy for Post-stroke Fatigue

Phase 1/2Completed

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Phase 1Completed

Clinical diagnosis of cortical and/or subcortical ischaemic stroke in an area perfused by the middle cerebral artery (i.e. stroke due to ischaemia resulting in infarct located in the basal ganglia, internal capsule or corona radiata)

Survived first 7 days following ischaemic stroke.

A motor handicap 7 days after the onset of the ischaemic stroke, which includes as a minimum, the inability to extend an arm to a horizontal position with the palm upward against gravity and to maintain the arm extended horizontally against gravity without obvious downward drift for 30 seconds.

You may not qualify if:

Prior history of stroke resulting in permanent, moderate to severe disability (i.e. Rankin Scale greater than 2) (other than the presenting ischaemic stroke)
Stroke due to haemorrhage
History of neurological or other disease resulting in significant functional impairment of the paretic arm impairing potential ability to pick up, lift and place a 2.5 cm3 block (e.g. Parkinson's disease, motor neuron disease, arthritis, Dupuytren's contracture or fixed anatomical abnormality)
Patient with a severe comorbid disorder, not expected to survive more than 12 months
Considered unlikely to be able to attend for all follow-up visits

Contact the study team to confirm eligibility.

Pathological Conditions, Signs and Symptoms

Necrosis

Primary Completion

March 2016

Actual (reported)

Study Completion

May 2016

Actual (reported)

Last Updated

December 19, 2016

Record last verified: 2016-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01859572
Data provider: ClinicalTrials.gov
Source updated: 2016-12-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:11 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations