Evaluating Neuroprotection in Aneurysm Coiling Therapy "ENACT"

Completed

Phase 2 Results

Trial Description

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

  • Placebo Drug
    Intervention Desc: single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
    ARM 1: Kind: Experimental
    Label: 2
    ARM 2: Kind: Experimental
    Label: Placebo
  • NA-1 Drug
    Intervention Desc: single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion
    ARM 1: Kind: Experimental
    Label: 1
    Description: 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.
    ARM 2: Kind: Experimental
    Label: NA-1
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Participants 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary To determine (1) the safety and tolerability of a single intravenous dose of NA-1 in patients undergoing endovascular repair of brain aneurysms and (2) the efficacy of NA-1 in reducing the volume of embolic strokes.
Secondary To determine the efficacy of a single intravenous dose of NA-1 in reducing (1) the number of embolic strokes, (2) procedurally-induced vascular cognitive impairment, and (3) the frequency of large strokes.
Primary Volume of New FLAIR Lesions(MRI) Enrolment, Days 2-4 No
Secondary Number of New DWI Lesions (MRI) Enrolment, Day 2-4 No
Secondary Number of New FLAIR Lesions (MRI) Enrolment, Days 2-4 No
Secondary Volume of New DWI Lesions (MRI) Enrolment, Days 2-4 No
Secondary National Institutes of Health Stroke Scale (NIHSS). Enrolment, Day 30 No
Secondary Modified Rankin Scale (mRS). Enrolment, Day 30 No

Sponsors