Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms (ENACT-2)
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.
Ruptured Intracranial Aneurysm
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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 Endovascular Repair of Ruptured Intracranial Aneurysms|
- Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.
- Modified Rankin Scale (mRS) [ Time Frame: 30-45 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Rate of subarachnoid hemorrhage related mortality over the 90 day study period.
- In-hospital length of stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]Duration of in-hospital length of stay.
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||April 2020|
|Estimated Primary Completion Date:||November 2019 (Final data collection date for primary outcome measure)|
20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier. Single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion.
Placebo Comparator: Placebo
Single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02056574
|United States, Arizona|
|Barrow Neurological Institute|
|Phoenix, Arizona, United States, 850139|
|United States, Colorado|
|Colorado Neurological Institute|
|Englewood, Colorado, United States, 801130000|
|United States, Michigan|
|University of Michigan - Neurosurgery|
|Ann Arbor, Michigan, United States, 481090000|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 537920000|
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Canada, Nova Scotia|
|QEII Health Sciences Centre - Halifax Infirmary|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Hopital de l'Enfant Jesus|
|Quebec City, Quebec, Canada, G1J 1Z4|
|Study Director:||Michael Tymianski, MD, PhD||NoNO Inc.|
|Principal Investigator:||Cameron G McDougall, MD||Barrow Neurological Institute|
|Principal Investigator:||Michael D Hill, MD||Foothills Medical Centre|