This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the endovascular procedure. The plasma concentrations of NA-1 will also be analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
185
single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion
single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
Barrow Neurological Institute
Phoenix, Arizona, United States
Stanford University Medical Center
Stanford, California, United States
Oregon Health and Science University
Portland, Oregon, United States
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
QEII Health Sciences Centre - Halifax Infirmary
Halifax, Nova Scotia, Canada
Hamilton Health Sciences General Site
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
...and 4 more locations
Volume of New FLAIR Lesions(MRI)
Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose
Time frame: Enrolment, Days 2-4
Number of New DWI Lesions (MRI)
Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.
Time frame: Enrolment, Day 2-4
Number of New FLAIR Lesions (MRI)
Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.
Time frame: Enrolment, Days 2-4
Volume of New DWI Lesions (MRI)
Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.
Time frame: Enrolment, Days 2-4
National Institutes of Health Stroke Scale (NIHSS).
The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.
Time frame: Enrolment, Day 30
Modified Rankin Scale (mRS).
The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.
Time frame: Enrolment, Day 30
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