Status:
COMPLETED
Safety and Efficacy Study in Acute Ischaemic Stroke
Lead Sponsor:
Vernalis (R&D) Ltd
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
Detailed Description
An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each....
Eligibility Criteria
Inclusion
- Summary of
- Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
- Aged 18 and above
- Provide consent
- Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive.
- NIHSS score greater than 5 or less than or equal to 20.
- Summary of
Exclusion
- Coma
- Stroke with unknown time of onset
- Minor stroke symptoms and sings (\<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
- Major stroke symptoms and signs (\>20 on the NIHSS)
- History of stroke in previous 6 weeks
- History of brain tumours
- CT scan results in an ASPECT score of \<5
- Haemorrhagic risk
- Abnormal laboratory values
- Positive urine pregnancy test, lactation or parturition within previous 30 days.
- Weight \>135 kg
- Uncontrolled hypertension.
- Raised blood glucose
- History of or current serious illness
- Participation in another clinical trial within 4 weeks of drug administration
- \-
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00144014
Start Date
August 1 2005
End Date
March 1 2009
Last Update
June 3 2016
Active Locations (28)
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1
Stroke Centre, Mayo Clinic
Scottsdale, Arizona, United States, 85054
2
UCLA Stroke Network
Los Angeles, California, United States, 90024
3
Neurology Medical Group of Diablo Valley
Walnut Creek, California, United States, 94598
4
Bethesda Memorial Hospital
Boynton Beach, Florida, United States, 33435