Clinical Trial: Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascul
Brief Summary: 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.
Detailed Summary:
Sponsor: NoNO Inc.
Current Primary Outcome: Modified Rankin Scale (mRS) [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Modified Rankin Scale (mRS) [ Time Frame: 30-45 days ]Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45.
- National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 90 days ]Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90.
- Mortality [ Time Frame: 90 days ]Rate of subarachnoid hemorrhage related mortality over the 90 day study period.
- In-hospital length of stay [ Time Frame: 90 days ]Duration of in-hospital length of stay.
Original Secondary Outcome: Same as current
Information By: NoNO Inc.
Dates:
Date Received: February 4, 2014
Date Started: November 2015
Date Completion: April 2020
Last Updated: August 3, 2015
Last Verified: March 2015