Evaluating Neuroprotection in Aneurysm Coiling Therapy

Phase 2

Completed

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 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 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
NA-1	NA-1	20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

Primary Outcome Measures

Name	Time	Method
Volume of New FLAIR Lesions(MRI)	Enrolment, Days 2-4	Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose

Secondary Outcome Measures

Name	Time	Method
Number of New DWI Lesions (MRI)	Enrolment, Day 2-4	Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.
Volume of New DWI Lesions (MRI)	Enrolment, Days 2-4	Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.
National Institutes of Health Stroke Scale (NIHSS).	Enrolment, Day 30	The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.
Number of New FLAIR Lesions (MRI)	Enrolment, Days 2-4	Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.
Modified Rankin Scale (mRS).	Enrolment, Day 30	The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.

Locations (14): Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
University of Alberta Hospital
🇨🇦
Edmonton, Alberta, Canada
QEII Health Sciences Centre - Halifax Infirmary
🇨🇦
Halifax, Nova Scotia, Canada
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Foothills Medical Centre
🇨🇦
Calgary, Alberta, Canada
The Ottawa Hospital - Civic Campus
🇨🇦
Ottawa, Ontario, Canada
Royal University Hospital
🇨🇦
Saskatoon, Saskatchewan, Canada
Hamilton Health Sciences General Site
🇨🇦
Hamilton, Ontario, Canada
Hôpital Notre-Dame du Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦
Montréal, Quebec, Canada
Hopital de l'Enfant Jesus
🇨🇦
Quebec City, Quebec, Canada
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Toronto Western Hospital
🇨🇦
Toronto, Ontario, Canada
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada