Clinical trial NCT00144014: Safety and Efficacy Study in Acute Ischaemic Stroke
Official title: A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Acute
Ischaemic
Stroke
Lead sponsor: Vernalis (R&D) Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Summary of Inclusion Criteria:

1. Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
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.

Summary of Exclusion Criteria:

1. Coma
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

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Primary outcomes:
measure: 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.
timeFrame: Ongoing
Secondary outcomes:
measure: To compare recanalisation rates across dose levels.
timeFrame: Ongoing
measure: To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.
timeFrame: Post-study completion
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Stroke Centre, Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Stroke Network
state: California
city: Walnut Creek
country: United States
facility: Neurology Medical Group of Diablo Valley
state: California
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Centre
state: Florida
city: Ocala
country: United States
facility: Ocala Neurodiagnostic Centre
state: Florida
city: Orlando
country: United States
facility: Florida Hospital of Neuroscience Institute
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Florida Neurovascular Institue Stroke Center
state: Florida
city: Maywood
country: United States
facility: Vascular Neurology, Loyola University Medical Center
state: Illinois
city: Louisville
country: United States
facility: Center for Advanced Medicine, Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Worcester
country: United States
facility: UMAS Memorial Medical Centre
state: Massachusetts
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Centre
state: Nevada
city: Reno
country: United States
facility: Washoe Stroke Center
state: Nevada
city: Charlotte
country: United States
facility: Stroke Centre, Neurological Institute, Carolinas Medical Centre
state: North Carolina
city: Winston Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University South Carolina Hospitals and Clinics
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Houston
country: United States
facility: Neurological Institute, The Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Division of Neuro-Ophthalmology, Virginia Commonwealth University
state: Virginia
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Care Centre
state: British Columbia
city: Victoria
country: Canada
facility: Centre for Stroke Research, Vancouver Island Health Research Centre
state: British Columbia
city: Mississauga
country: Canada
facility: 71 King Street West
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Hospital Charles LeMoyne
Study officials:
affiliation: Foothills Hosptial
name: Michael Hill
role: PRINCIPAL_INVESTIGATOR
References: