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Evaluating Neuroprotection in Aneurysm Coiling Therapy

NCT00728182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2013-10-17

Study results available
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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.

Conditions

Interventions

DRUG

NA-1

single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

DRUG

Placebo

single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Sponsors & Collaborators

  • Arbor Vita Corporation

    collaborator INDUSTRY

  • NoNO Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Hill, M.D. · Foothills Medical Centre, University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00728182 on ClinicalTrials.gov