Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2005-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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V10153, 1.0 mg/kg
Single acute intravenous bolus dose
V10153
Single acute intravenous bolus dose up to 10 mg/kg
V10153, 2.5 mg/kg
Single acute intravenous bolus dose
V10153
Single acute intravenous bolus dose up to 10 mg/kg
V10153, 5.0 mg/kg
Single acute intravenous bolus dose
V10153
Single acute intravenous bolus dose up to 10 mg/kg
V10153, 7.5 mg/kg
Single acute intravenous bolus dose
V10153
Single acute intravenous bolus dose up to 10 mg/kg
V10153, 10 mg/kg
Single acute intravenous bolus dose
V10153
Single acute intravenous bolus dose up to 10 mg/kg
Interventions
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V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 18 and above
3. Provide consent
4. 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.
5. NIHSS score greater than 5 or less than or equal to 20.
Exclusion Criteria
2. Stroke with unknown time of onset
3. Minor stroke symptoms and sings (\<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
4. Major stroke symptoms and signs (\>20 on the NIHSS)
5. History of stroke in previous 6 weeks
6. History of brain tumours
7. CT scan results in an ASPECT score of \<5
8. Haemorrhagic risk
9. Abnormal laboratory values
10. Positive urine pregnancy test, lactation or parturition within previous 30 days.
11. Weight \>135 kg
12. Uncontrolled hypertension.
13. Raised blood glucose
14. History of or current serious illness
15. Participation in another clinical trial within 4 weeks of drug administration
\-
18 Years
ALL
No
Sponsors
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Vernalis (R&D) Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Hill
Role: PRINCIPAL_INVESTIGATOR
Foothills Hosptial
Locations
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Stroke Centre, Mayo Clinic
Scottsdale, Arizona, United States
UCLA Stroke Network
Los Angeles, California, United States
Neurology Medical Group of Diablo Valley
Walnut Creek, California, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, United States
Bradenton Research Centre
Bradenton, Florida, United States
Ocala Neurodiagnostic Centre
Ocala, Florida, United States
Florida Hospital of Neuroscience Institute
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Florida Neurovascular Institue Stroke Center
Tampa, Florida, United States
Vascular Neurology, Loyola University Medical Center
Maywood, Illinois, United States
Center for Advanced Medicine, Jewish Hospital
Louisville, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
UMAS Memorial Medical Centre
Worcester, Massachusetts, United States
Sunrise Hospital and Medical Centre
Las Vegas, Nevada, United States
Washoe Stroke Center
Reno, Nevada, United States
Stroke Centre, Neurological Institute, Carolinas Medical Centre
Charlotte, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Medical University South Carolina Hospitals and Clinics
Charleston, South Carolina, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Neurological Institute, The Methodist Hospital
Houston, Texas, United States
Division of Neuro-Ophthalmology, Virginia Commonwealth University
Richmond, Virginia, United States
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Centre for Stroke Research, Vancouver Island Health Research Centre
Victoria, British Columbia, Canada
71 King Street West
Mississauga, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Hospital Charles LeMoyne
Québec, , Canada
Countries
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Other Identifiers
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V10153-2S-01
Identifier Type: -
Identifier Source: org_study_id
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