Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

Completed

Phase 3 Results

Trial Description

The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.

Detailed Description

This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days post stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.

Conditions

Interventions

  • NeuroThera Laser System (NTS) Other
    Intervention Desc: Treatment with light.
  • NeuroThera┬« Laser System Device
    Intervention Desc: Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
    ARM 1: Kind: Experimental
    Label: Transcranial Laser Therapy
    ARM 2: Kind: Experimental
    Label: Sham control procedure

Trial Design

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

Patient Involvement

CT scan at diagnosis; treatment with NeuroThera Laser System; mRS score and NIHSS score at 30, 60, and 90 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Disability scale (mRS)score at 90 days; safety of the treatment procedure.
Secondary Functional neurological scale(NIHSS)over time.
Primary Disability scale (mRS)score at 90 days; safety of the treatment procedure at baseline, day 5, 30, 60 and 90 post treatment Yes
Secondary Functional neurological scale(NIHSS)over time at baseline, Day 5, 30, 60 and 90 No

Sponsors