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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]

Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.


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