Status:
COMPLETED
Observational Study of Ischaemic Stroke
Lead Sponsor:
ReNeuron Limited
Conditions:
Stroke
Motor Activity
Eligibility:
All Genders
18+ years
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...
Detailed Description
Experience of conducting a Phase I study of an advanced medicinal therapy for ischaemic stroke and planning a Phase II efficacy study for this indication has revealed a number of opportunities to faci...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01859572
Start Date
February 1 2014
End Date
May 1 2016
Last Update
December 19 2016
Active Locations (1)
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1
Glasgow Southern General Hospital
Glasgow, United Kingdom, G51 4TF