NCT00728182

Evaluating Neuroprotection in Aneurysm Coiling Therapy

A Phase II, Multicenter, Randomized, Fasting, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Male and Female Patients Undergoing Endovascular Repair of Brain Aneurysms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: NoNO Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	NA-1	single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion
DRUG	Placebo	single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2008-08-05
• Last updated: 2013-10-17
• Results posted: 2013-10-17

Locations

14 sites across 2 countries: United States, Canada