Evaluating Neuroprotection in Aneurysm Coiling Therapy
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
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.