Safety and Efficacy Study in Acute Ischaemic Stroke

Phase 2

Completed

Conditions: Stroke

Interventions: Drug: V10153

Registration Number: NCT00144014

Lead Sponsor: Vernalis (R&D) Ltd

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. Escalation to higher doses will occur following review of safety data from the previous dose.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V10153, 1.0 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 2.5 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 5.0 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 7.5 mg/kg	V10153	Single acute intravenous bolus dose
V10153, 10 mg/kg	V10153	Single acute intravenous bolus dose

Primary Outcome Measures

Name	Time	Method
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.	Ongoing

Secondary Outcome Measures

Name	Time	Method
To compare recanalisation rates across dose levels.	Ongoing
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.	Post-study completion

Trial Locations

Locations (28): Tallahassee Memorial Hospital
🇺🇸
Tallahassee, Florida, United States
UMAS Memorial Medical Centre
🇺🇸
Worcester, Massachusetts, United States
UCLA Stroke Network
🇺🇸
Los Angeles, California, United States
Neurology Medical Group of Diablo Valley
🇺🇸
Walnut Creek, California, United States
71 King Street West
🇨🇦
Mississauga, Ontario, Canada
Hospital Charles LeMoyne
🇨🇦
Quebec, Canada
Division of Neuro-Ophthalmology, Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
Bradenton Research Centre
🇺🇸
Bradenton, Florida, United States
Washoe Stroke Center
🇺🇸
Reno, Nevada, United States
University of Pennsylvania Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Neurological Institute, The Methodist Hospital
🇺🇸
Houston, Texas, United States
Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, 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
Stroke Centre, Mayo Clinic
🇺🇸
Scottsdale, Arizona, United States
Bethesda Memorial Hospital
🇺🇸
Boynton Beach, Florida, United States
Vascular Neurology, Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Forsyth Medical Center
🇺🇸
Winston Salem, North Carolina, United States
Ocala Neurodiagnostic Centre
🇺🇸
Ocala, Florida, United States
Medical University South Carolina Hospitals and Clinics
🇺🇸
Charleston, South Carolina, United States
Erlanger Health System
🇺🇸
Chattanooga, Tennessee, United States
Stroke Centre, Neurological Institute, Carolinas Medical Centre
🇺🇸
Charlotte, North Carolina, United States
Sunrise Hospital and Medical Centre
🇺🇸
Las Vegas, Nevada, United States
Florida Hospital of Neuroscience Institute
🇺🇸
Orlando, Florida, United States
Center for Advanced Medicine, Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
Florida Neurovascular Institue Stroke Center
🇺🇸
Tampa, Florida, United States
University of Louisville Hospital
🇺🇸
Louisville, Kentucky, United States
Royal University Hospital
🇨🇦
Saskatoon, Saskatchewan, Canada