Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00728182
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2008-08-01
Brief Title:
Evaluating Neuroprotection in Aneurysm Coiling Therapy
Sponsor:
NoNO Inc
Organization:
NoNO Inc
Study Overview
Official Title:
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
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENACT
Brief 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 260 mgkg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None