This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial 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 at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Barrow Neurological Institute
Phoenix, Arizona, United States
Colorado Neurological Institute
Englewood, Colorado, United States
University of Michigan - Neurosurgery
Ann Arbor, Michigan, United States
Modified Rankin Scale (mRS)
Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.
Time frame: 90 days
Modified Rankin Scale (mRS)
Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45.
Time frame: 30-45 days
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90.
Time frame: 90 days
Mortality
Rate of subarachnoid hemorrhage related mortality over the 90 day study period.
Time frame: 90 days
In-hospital length of stay
Duration of in-hospital length of stay.
Time frame: 90 days
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Oregon Health and Science University
Portland, Oregon, United States
University of Wisconsin
Madison, Wisconsin, United States
Foothills Medical Centre
Calgary, Alberta, Canada
QEII Health Sciences Centre - Halifax Infirmary
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
...and 2 more locations