Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms (ENACT-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02056574|
Recruitment Status : Withdrawn
First Posted : February 6, 2014
Last Update Posted : August 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage Ruptured Intracranial Aneurysm||Drug: NA-1 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||April 2020|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|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|